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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 2:12 AM

Ignite Modification Date: 2025-12-29 @ 10:55 AM

Study NCT ID: NCT00830960

Status: COMPLETED

Last Update Posted: 2011-11-02

First Post: 2009-01-27

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Primary = participant weight ≥60 kg and age \\<75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.', 'otherNumAtRisk': 117, 'otherNumAffected': 54, 'seriousNumAtRisk': 117, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Primary = participant weight ≥60 kg and age \\<75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day', 'otherNumAtRisk': 122, 'otherNumAffected': 38, 'seriousNumAtRisk': 122, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Primary = participant weight ≥60 kg and age \\<75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.', 'otherNumAtRisk': 133, 'otherNumAffected': 45, 'seriousNumAtRisk': 133, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Primary = participant weight ≥60 kg and age \\<75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day', 'otherNumAtRisk': 135, 'otherNumAffected': 49, 'seriousNumAtRisk': 135, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Low Weight/Elderly = participant weight \\<60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.', 'otherNumAtRisk': 91, 'otherNumAffected': 28, 'seriousNumAtRisk': 91, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Low Weight/Elderly = participant weight \\<60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day', 'otherNumAtRisk': 93, 'otherNumAffected': 34, 'seriousNumAtRisk': 93, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Clopidogrel 300/75 No Weight', 'description': "Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day", 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60-mg LD Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD'}, {'id': 'OG001', 'title': 'Prasugrel 30-mg LD Primary', 'description': 'Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).'}, {'id': 'OG002', 'title': 'Clopidogrel 300-mg LD Primary', 'description': 'Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'spread': '104.86', 'groupId': 'OG000'}, {'value': '124.2', 'spread': '117.28', 'groupId': 'OG001'}, {'value': '261.8', 'spread': '83.87', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square (LS) Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-183', 'ciLowerLimit': '-229', 'ciUpperLimit': '-137', 'pValueComment': 'Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-139', 'ciLowerLimit': '-177', 'ciUpperLimit': '-102', 'pValueComment': 'Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At 4 hours following LD administration', 'description': 'ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.\n\nEfficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.', 'unitOfMeasure': 'PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) LD population\n\nPPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations\n\nLD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60-mg LD Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD'}, {'id': 'OG001', 'title': 'Prasugrel 30-mg LD Primary', 'description': 'Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).'}, {'id': 'OG002', 'title': 'Clopidogrel 300-mg LD Primary', 'description': 'Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.'}, {'id': 'OG003', 'title': 'Prasugrel 30-mg LD Low Weight/Elderly', 'description': 'Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.'}, {'id': 'OG004', 'title': 'Clopidogrel 300-mg LD Low Weight/Elderly', 'description': 'Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.'}], 'classes': [{'title': '30 min (n=40, n=79, n=48, n=33, n=34)', 'categories': [{'measurements': [{'value': '250.5', 'spread': '109.02', 'groupId': 'OG000'}, {'value': '280.4', 'spread': '112.58', 'groupId': 'OG001'}, {'value': '312.1', 'spread': '72.41', 'groupId': 'OG002'}, {'value': '311.2', 'spread': '96.46', 'groupId': 'OG003'}, {'value': '379.5', 'spread': '53.29', 'groupId': 'OG004'}]}]}, {'title': '2 hours (n=37, n=80, n=49, n=33, n=33)', 'categories': [{'measurements': [{'value': '116.9', 'spread': '116.48', 'groupId': 'OG000'}, {'value': '178.8', 'spread': '128.37', 'groupId': 'OG001'}, {'value': '289.5', 'spread': '71.77', 'groupId': 'OG002'}, {'value': '171.8', 'spread': '123.37', 'groupId': 'OG003'}, {'value': '339.0', 'spread': '74.03', 'groupId': 'OG004'}]}]}, {'title': '4 hours (n=35, n=79, n=44, n=33, n=33)', 'categories': [{'measurements': [{'value': '88.5', 'spread': '104.86', 'groupId': 'OG000'}, {'value': '124.2', 'spread': '117.28', 'groupId': 'OG001'}, {'value': '261.8', 'spread': '83.87', 'groupId': 'OG002'}, {'value': '127.3', 'spread': '106.38', 'groupId': 'OG003'}, {'value': '337.8', 'spread': '85.15', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57', 'ciLowerLimit': '-97', 'ciUpperLimit': '-17', 'pValueComment': 'P-value for 30 minutes post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0365', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35', 'ciLowerLimit': '-68', 'ciUpperLimit': '-2', 'pValueComment': 'P-value for 30 minutes post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-68', 'ciLowerLimit': '-104', 'ciUpperLimit': '-32', 'pValueComment': 'P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-160', 'ciLowerLimit': '-211', 'ciUpperLimit': '-110', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-115', 'ciLowerLimit': '-156', 'ciUpperLimit': '-73', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-171', 'ciLowerLimit': '-216', 'ciUpperLimit': '-125', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-212', 'ciLowerLimit': '-259', 'ciUpperLimit': '-167', 'pValueComment': 'P-value for 4 hours post-LD\n\nLinear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At 30 minutes, 2 hours, and 4 hours following LD administration', 'description': 'Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.\n\nData for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.\n\nADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.', 'unitOfMeasure': 'PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations\n\nLD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'title': '30 days (n=69, n=63, n=69, n=78, n=47, n=48)', 'categories': [{'measurements': [{'value': '71.6', 'spread': '65.56', 'groupId': 'OG000'}, {'value': '99.3', 'spread': '72.63', 'groupId': 'OG001'}, {'value': '150.8', 'spread': '77.76', 'groupId': 'OG002'}, {'value': '206.5', 'spread': '72.68', 'groupId': 'OG003'}, {'value': '134.2', 'spread': '80.29', 'groupId': 'OG004'}, {'value': '237.5', 'spread': '108.32', 'groupId': 'OG005'}]}]}, {'title': '90 Days (n=60, n=57, n=64, n=72, n=43, n=42)', 'categories': [{'measurements': [{'value': '64.8', 'spread': '55.99', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '91.75', 'groupId': 'OG001'}, {'value': '138.5', 'spread': '80.42', 'groupId': 'OG002'}, {'value': '188.3', 'spread': '81.24', 'groupId': 'OG003'}, {'value': '128.5', 'spread': '70.42', 'groupId': 'OG004'}, {'value': '219.6', 'spread': '95.06', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-119', 'ciLowerLimit': '-166', 'ciUpperLimit': '-73', 'pValueComment': 'P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU was prasugrel - clopidogrel.', 'statisticalMethod': 'LS Mean Difference in PRU', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-113', 'ciLowerLimit': '-154', 'ciUpperLimit': '-73', 'pValueComment': 'P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU was prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-85', 'ciLowerLimit': '-121', 'ciUpperLimit': '-48', 'pValueComment': 'P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU was prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0647', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35', 'ciLowerLimit': '-72', 'ciUpperLimit': '2', 'pValueComment': 'P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU was prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100', 'ciLowerLimit': '-143', 'ciUpperLimit': '-57', 'pValueComment': 'P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect\n\nDifference in PRU was prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At 30 Days and 90 days during MD therapy', 'description': 'Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.\n\nData for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.\n\nADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.', 'unitOfMeasure': 'PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60-mg LD Primary', 'description': 'Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.'}, {'id': 'OG001', 'title': 'Prasugrel 30-mg LD Primary', 'description': 'Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).'}, {'id': 'OG002', 'title': 'Clopidogrel 300-mg LD Primary', 'description': 'Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.'}, {'id': 'OG003', 'title': 'Prasugrel 30-mg LD Low Weight/Elderly', 'description': 'Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.'}, {'id': 'OG004', 'title': 'Clopidogrel 300-mg LD Low Weight/Elderly', 'description': 'Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.'}], 'classes': [{'title': '30 minutes (n=40, n=79, n=47, n=32, n=31)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '-5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '2 hours (n=37, n=80, n=48, n=33, n=33)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '-2', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '4 hours (n=34, n=79, n=43, n=33, n=33)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'ciLowerLimit': '4', 'ciUpperLimit': '27', 'pValueComment': 'P-value for 30 minutes post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0647', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-1', 'ciUpperLimit': '18', 'pValueComment': 'P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0054', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '3', 'ciUpperLimit': '19', 'pValueComment': 'P-value for 30 minutes post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51', 'ciLowerLimit': '36', 'ciUpperLimit': '66', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36', 'ciLowerLimit': '23', 'ciUpperLimit': '48', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49', 'ciLowerLimit': '36', 'ciUpperLimit': '61', 'pValueComment': 'P-value for 2 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62', 'ciLowerLimit': '47', 'ciUpperLimit': '76', 'pValueComment': 'P-value for 4 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48', 'ciLowerLimit': '36', 'ciUpperLimit': '59', 'pValueComment': 'P-value for 4 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56', 'ciLowerLimit': '44', 'ciUpperLimit': '68', 'pValueComment': 'P-value for 4 hours post-LD\n\nLinear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes, 2 hours, and 4 hours following LD administration', 'description': 'A higher percentage (percent inhibition least squares mean \\[LS mean\\]) represents greater platelet inhibition.', 'unitOfMeasure': 'Percent inhibition', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'title': '30 Days (n=69, n=63, n=68, n=78, n=47, n=48)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}]}, {'title': '90 Days (n=60, n=57, n=64, n=72, n=43, n=42)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38', 'ciLowerLimit': '27', 'ciUpperLimit': '50', 'pValueComment': 'P-value for 30 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32', 'ciLowerLimit': '21', 'ciUpperLimit': '42', 'pValueComment': 'P-value for 30 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0026', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17', 'ciLowerLimit': '6', 'ciUpperLimit': '28', 'pValueComment': 'P-value for 30 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37', 'ciLowerLimit': '24', 'ciUpperLimit': '50', 'pValueComment': 'P-value for 30 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35', 'ciLowerLimit': '18', 'ciUpperLimit': '52', 'pValueComment': 'P-value for 90 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28', 'ciLowerLimit': '13', 'ciUpperLimit': '44', 'pValueComment': 'P-value for 90 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.1898', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '-5', 'ciUpperLimit': '27', 'pValueComment': 'P-value for 90 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Percent Inhibition', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32', 'ciLowerLimit': '18', 'ciUpperLimit': '45', 'pValueComment': 'P-value for 90 days post-LD\n\nLinear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days and at 90 days during MD therapy', 'description': 'A higher percentage (percent inhibition least squares mean \\[LS mean\\]) represents greater platelet inhibition.', 'unitOfMeasure': 'Percent inhibition', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) MD population\n\nPPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations\n\nMD population: received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'title': 'Fatal MI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Nonfatal MI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Fatal Stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Nonfatal Stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Definite Stent Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'UTVR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting \\>24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.\n\nStent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.\n\nUTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)\n\nFAS: all randomized subjects who received at least 1 dose of study drug'}, {'type': 'PRIMARY', 'title': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age \\<75 years)'}], 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'spread': '65.56', 'groupId': 'OG000'}, {'value': '99.3', 'spread': '72.63', 'groupId': 'OG001'}, {'value': '150.8', 'spread': '77.76', 'groupId': 'OG002'}, {'value': '206.5', 'spread': '72.68', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-110', 'ciLowerLimit': '-143', 'ciUpperLimit': '-76', 'pValueComment': 'Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-92', 'ciLowerLimit': '-123', 'ciUpperLimit': '-60', 'pValueComment': 'Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference in PRU', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51', 'ciLowerLimit': '-83', 'ciUpperLimit': '-19', 'pValueComment': 'Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.\n\nDifference in PRU = prasugrel - clopidogrel.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At 30 days during MD therapy', 'description': 'Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \\<75 years).\n\nADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.', 'unitOfMeasure': 'PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) MD population\n\nPPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations\n\nMD population: received percutaneous coronary intervention (PCI) for index event'}, {'type': 'SECONDARY', 'title': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.\n\nCV death: death caused by CV event or not clearly attributable to non-CV causes.\n\nNonfatal MI: per adapted American College of Cardiology definition.\n\nNonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.\n\nUTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.\n\nRecurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of definite or probable stent thrombosis.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.255', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.427', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.683', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.034', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Risk was defined as the number of participants with events of all-cause death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'title': '≤3 Days of LD Major', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': '≤3 Days of LD Life Threatening', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': '≤3 Days of LD Minor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '≤3 Days of LD Minimal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': '>3 Days of LD Major', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': '>3 Days of LD Life Threatening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '>3 Days of LD Minor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': '>3 Days of LD Minimal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.\n\nMajor bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.\n\nMinor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but \\<5 gm/dL from baseline.\n\nInsignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug\n\nTwo (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table.'}, {'type': 'SECONDARY', 'title': 'Incidence of CABG-related TIMI Major or Minor Bleeding.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of study (90 days)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug\n\nIn 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event'}, {'type': 'SECONDARY', 'title': 'Inpatient Healthcare Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': 'Initial hospitalization, 30 days, 90 days', 'description': 'Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 PD', 'description': 'Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 PD', 'description': 'Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 PD', 'description': 'Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 PD', 'description': 'Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.'}], 'classes': [{'title': '4 hours, EM (n=15, n=18, n=27, n=31)', 'categories': [{'measurements': [{'value': '-162.9', 'spread': '154.30', 'groupId': 'OG000', 'lowerLimit': '-397', 'upperLimit': '144'}, {'value': '-198.8', 'spread': '90.71', 'groupId': 'OG001', 'lowerLimit': '-230', 'upperLimit': '215'}, {'value': '-217.2', 'spread': '83.52', 'groupId': 'OG002'}, {'value': '-9.7', 'spread': '72.30', 'groupId': 'OG003'}]}]}, {'title': '4 hours, RM (n=18, n=21, n=45, n=45)', 'categories': [{'measurements': [{'value': '-245.9', 'spread': '102.77', 'groupId': 'OG000'}, {'value': '-183.3', 'spread': '123.29', 'groupId': 'OG001'}, {'value': '-181.9', 'spread': '129.47', 'groupId': 'OG002'}, {'value': '-22.2', 'spread': '72.84', 'groupId': 'OG003'}]}]}, {'title': '30 days, EM (n=17, n=21, n=31, n=30)', 'categories': [{'measurements': [{'value': '-193.9', 'spread': '98.17', 'groupId': 'OG000'}, {'value': '-196.5', 'spread': '88.90', 'groupId': 'OG001'}, {'value': '-187.5', 'spread': '94.79', 'groupId': 'OG002'}, {'value': '-110.6', 'spread': '83.49', 'groupId': 'OG003'}]}]}, {'title': '30 days, RM (n=19, n=21. n=43, n=47)', 'categories': [{'measurements': [{'value': '-250.3', 'spread': '90.17', 'groupId': 'OG000'}, {'value': '-208.5', 'spread': '74.23', 'groupId': 'OG001'}, {'value': '-152.8', 'spread': '88.97', 'groupId': 'OG002'}, {'value': '-81.7', 'spread': '70.56', 'groupId': 'OG003'}]}]}, {'title': '90 days, EM (n=12, n=18, n=30, n=28)', 'categories': [{'measurements': [{'value': '-203.8', 'spread': '102.89', 'groupId': 'OG000'}, {'value': '-210.0', 'spread': '110.68', 'groupId': 'OG001'}, {'value': '-187.2', 'spread': '92.70', 'groupId': 'OG002'}, {'value': '-141.0', 'spread': '75.58', 'groupId': 'OG003'}]}]}, {'title': '90 days, RM (n=17, n=21, n=36, n=41)', 'categories': [{'measurements': [{'value': '-267.5', 'spread': '70.86', 'groupId': 'OG000'}, {'value': '-225.7', 'spread': '76.52', 'groupId': 'OG001'}, {'value': '-164.1', 'spread': '75.90', 'groupId': 'OG002'}, {'value': '-100.7', 'spread': '92.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase', 'description': 'The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.\n\nParticipants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).\n\nA higher value for change in PRU indicates a greater level of platelet inhibition.', 'unitOfMeasure': 'Change in PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.\n\nParticipants classified as EM or RM. Invalid measurements of PRU were excluded.'}, {'type': 'SECONDARY', 'title': 'Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'OG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'OG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 90 days', 'description': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'FG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'FG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'FG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'FG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'FG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of participants "STARTED" equals the number of participants randomized.', 'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '137'}, {'groupId': 'FG003', 'numSubjects': '138'}, {'groupId': 'FG004', 'numSubjects': '96'}, {'comment': 'Total 720 participants were randomized; 1 was not included in a cohort as baseline weight missing.', 'groupId': 'FG005', 'numSubjects': '100'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'comment': 'Baseline Characteristics (below) include those who received ≥1 dose study drug, not all who STARTED.', 'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '135'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'comment': '6 participants not completed due to death; 1 additional death occurred after study discontinuation.', 'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'No study drug received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'This study had 4 treatment arms and had 2 cohorts; a Primary Cohort (≥60 kilograms \\[kg\\] and age \\<75 years) and a Low Weight/Elderly cohort (\\<60 kg or age ≥75 years). Randomization was stratified by country, cohort and anticipated glycoprotein (GP) IIb/IIIa inhibitor use.', 'preAssignmentDetails': 'One participant who was enrolled based on weight \\>60 kg was not assigned to primary cohort due to no weight entered in case report form.\n\nLow Weight/Elderly Cohort was only assigned to prasugrel 30-mg loading dose (LD)/5-mg maintenance dose (MD) or clopidogrel 300-mg LD/75-mg MD due to evidence of increased bleeding risk for these populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}, {'value': '691', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Prasugrel 60/10 Primary', 'description': 'Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)\n\nReporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug.'}, {'id': 'BG001', 'title': 'Prasugrel 30/7.5 Primary', 'description': 'Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'BG002', 'title': 'Prasugrel 30/5 Primary', 'description': 'Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'BG003', 'title': 'Clopidogrel 300/75 Primary', 'description': 'Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \\<75 years)'}, {'id': 'BG004', 'title': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'BG005', 'title': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \\<60 kg or age ≥75 years)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'Mean Age Overall', 'categories': [{'measurements': [{'value': '58.3', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '9.47', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '10.49', 'groupId': 'BG002'}, {'value': '58.3', 'spread': '8.95', 'groupId': 'BG003'}, {'value': '68.5', 'spread': '9.74', 'groupId': 'BG004'}, {'value': '69.1', 'spread': '12.08', 'groupId': 'BG005'}, {'value': '60.8', 'spread': '11.13', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Total mean age is based on all randomized participants who received at least 1 dose of study drug, and for whom information was available (n=689).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '174', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '517', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '483', 'groupId': 'BG006'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'BMI', 'categories': [{'measurements': [{'value': '25.86', 'spread': '2.907', 'groupId': 'BG000'}, {'value': '25.75', 'spread': '2.990', 'groupId': 'BG001'}, {'value': '26.06', 'spread': '2.637', 'groupId': 'BG002'}, {'value': '26.19', 'spread': '2.999', 'groupId': 'BG003'}, {'value': '22.02', 'spread': '4.106', 'groupId': 'BG004'}, {'value': '22.10', 'spread': '3.166', 'groupId': 'BG005'}, {'value': '24.74', 'spread': '3.510', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'BMI is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m²)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Qualifying Diagnosis', 'classes': [{'title': 'Unstable angina (UA)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}]}, {'title': 'Non-ST segment elevation myocardial infarction', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}]}, {'title': 'ST segment elevation myocardial infarction', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '395', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-22', 'studyFirstSubmitDate': '2009-01-27', 'resultsFirstSubmitDate': '2011-06-17', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-22', 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)', 'timeFrame': 'At 4 hours following LD administration', 'description': 'ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.\n\nEfficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.'}, {'measure': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort', 'timeFrame': 'At 30 days during MD therapy', 'description': 'Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \\<75 years).\n\nADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.'}], 'secondaryOutcomes': [{'measure': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.', 'timeFrame': 'At 30 minutes, 2 hours, and 4 hours following LD administration', 'description': 'Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.\n\nData for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.\n\nADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.'}, {'measure': 'Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort', 'timeFrame': 'At 30 Days and 90 days during MD therapy', 'description': 'Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.\n\nData for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.\n\nADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.\n\nObserved PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.'}, {'measure': 'Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort', 'timeFrame': '30 minutes, 2 hours, and 4 hours following LD administration', 'description': 'A higher percentage (percent inhibition least squares mean \\[LS mean\\]) represents greater platelet inhibition.'}, {'measure': 'Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort', 'timeFrame': '30 days and at 90 days during MD therapy', 'description': 'A higher percentage (percent inhibition least squares mean \\[LS mean\\]) represents greater platelet inhibition.'}, {'measure': 'Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting \\>24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.\n\nStent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.\n\nUTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure'}, {'measure': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.\n\nCV death: death caused by CV event or not clearly attributable to non-CV causes.\n\nNonfatal MI: per adapted American College of Cardiology definition.\n\nNonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.'}, {'measure': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.\n\nUTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.'}, {'measure': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.\n\nRecurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.'}, {'measure': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.'}, {'measure': 'Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition', 'timeFrame': '30 days and 90 days', 'description': 'Risk was defined as the number of participants with events of definite or probable stent thrombosis.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.'}, {'measure': 'Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition', 'timeFrame': '90 days', 'description': 'Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.\n\nAs a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.'}, {'measure': 'Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Risk was defined as the number of participants with events of all-cause death.'}, {'measure': 'Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding', 'timeFrame': 'Randomization through end of study (90 days)', 'description': 'Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.\n\nMajor bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.\n\nMinor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but \\<5 gm/dL from baseline.\n\nInsignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.'}, {'measure': 'Incidence of CABG-related TIMI Major or Minor Bleeding.', 'timeFrame': 'Randomization through end of study (90 days)'}, {'measure': 'Inpatient Healthcare Resource Utilization', 'timeFrame': 'Initial hospitalization, 30 days, 90 days', 'description': 'Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.'}, {'measure': 'Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary', 'timeFrame': 'Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase', 'description': 'The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.\n\nParticipants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).\n\nA higher value for change in PRU indicates a greater level of platelet inhibition.'}, {'measure': 'Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)', 'timeFrame': '30 days and 90 days', 'description': 'Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)\n* A person who is of East or Southeast Asian descent\n* A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study\n* If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control\n\nExclusion Criteria:\n\n* A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure\n* A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)\n* A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)\n* A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study\n* A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued\n* A person who has a severe liver disease, such as cirrhosis\n* A person who has a condition such as alcoholism, mental illness, or drug dependence'}, 'identificationModule': {'nctId': 'NCT00830960', 'briefTitle': 'A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Comparison of Platelet Inhibition Following Prasugrel or Clopidogrel Administration in Asian Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '11299'}, 'secondaryIdInfos': [{'id': 'H7T-MC-TACE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prasugrel 60/10 Primary', 'description': 'Loading dose 60 mg followed by maintenance dose 10 mg/day', 'interventionNames': ['Drug: Prasugrel']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel 30/7.5 Primary', 'description': 'Loading dose 30 mg followed by maintenance dose 7.5 mg/day', 'interventionNames': ['Drug: Prasugrel']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel 30/5 Primary', 'description': 'Loading dose 30 mg followed by maintenance dose 5 mg/day', 'interventionNames': ['Drug: Prasugrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel 300/75 Primary', 'description': 'Loading dose 300 mg followed by maintenance dose 75 mg/day', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel 30/5 Low Weight/Elderly', 'description': 'Loading dose 30 mg followed by maintenance dose 5 mg/day', 'interventionNames': ['Drug: Prasugrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel 300/75 Low Weight/Elderly', 'description': 'Loading dose 300 mg followed by maintenance dose 75 mg/day', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Prasugrel', 'type': 'DRUG', 'otherNames': ['LY640315', 'Effient', 'Efient', 'CS-747'], 'description': 'Oral, daily, 90 days', 'armGroupLabels': ['Prasugrel 30/5 Low Weight/Elderly', 'Prasugrel 30/5 Primary', 'Prasugrel 30/7.5 Primary', 'Prasugrel 60/10 Primary']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Oral, daily, 90 days', 'armGroupLabels': ['Clopidogrel 300/75 Low Weight/Elderly', 'Clopidogrel 300/75 Primary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510080', 'city': 'Guangzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310009', 'city': 'Hangzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '210008', 'city': 'Nanjing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '110016', 'city': 'Shenyang', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '325027', 'city': 'Wenzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '501-757', 'city': 'Kwangju', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'zip': '463-707', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '135 720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}