Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-30 @ 11:59 PM
Study NCT ID:
NCT01107912
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2010-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive 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': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.', 'otherNumAtRisk': 73, 'otherNumAffected': 20, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.', 'otherNumAtRisk': 71, 'otherNumAffected': 31, 'seriousNumAtRisk': 71, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.', 'otherNumAtRisk': 72, 'otherNumAffected': 25, 'seriousNumAtRisk': 72, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.', 'otherNumAtRisk': 79, 'otherNumAffected': 23, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.', 'otherNumAtRisk': 82, 'otherNumAffected': 39, 'seriousNumAtRisk': 82, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.', 'otherNumAtRisk': 79, 'otherNumAffected': 23, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 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'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infusion site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, 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{'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 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1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG001', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '78.00', 'groupId': 'OG000', 'lowerLimit': '72.00', 'upperLimit': '83.50'}, {'value': '75.00', 'groupId': 'OG001', 'lowerLimit': '71.00', 'upperLimit': '83.00'}]}]}, {'title': 'Period 1 (12 days) (n=71, 79)', 'categories': [{'measurements': [{'value': '58.00', 'groupId': 'OG000', 'lowerLimit': '50.00', 'upperLimit': '65.00'}, {'value': '46.00', 'groupId': 'OG001', 'lowerLimit': '39.00', 'upperLimit': '52.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate of the difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.00', 'ciLowerLimit': '1.00', 'ciUpperLimit': '9.00', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 days', 'description': 'Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.', 'unitOfMeasure': 'percentage of aggregation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.'}, {'type': 'SECONDARY', 'title': 'Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.'}, {'id': 'OG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}, {'id': 'OG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.'}, {'id': 'OG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}], 'classes': [{'title': 'Baseline (n=68, 66, 67, 71, 72, 72)', 'categories': [{'measurements': [{'value': '85.62', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '85.66', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '85.60', 'spread': '4.31', 'groupId': 'OG002'}, {'value': '86.10', 'spread': '5.31', 'groupId': 'OG003'}, {'value': '86.18', 'spread': '5.32', 'groupId': 'OG004'}, {'value': '86.18', 'spread': '5.32', 'groupId': 'OG005'}]}]}, {'title': 'Day 12 (n=67, 65, 67, 73, 74, 73)', 'categories': [{'measurements': [{'value': '44.30', 'spread': '18.87', 'groupId': 'OG000'}, {'value': '22.66', 'spread': '11.90', 'groupId': 'OG001'}, {'value': '54.95', 'spread': '18.86', 'groupId': 'OG002'}, {'value': '54.72', 'spread': '18.67', 'groupId': 'OG003'}, {'value': '27.74', 'spread': '15.84', 'groupId': 'OG004'}, {'value': '54.53', 'spread': '21.82', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 12', 'description': 'Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.', 'unitOfMeasure': 'percentage platelet reactive index (PRI)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.'}, {'id': 'OG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}, {'id': 'OG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.'}, {'id': 'OG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '315.63', 'spread': '45.98', 'groupId': 'OG000'}, {'value': '314.11', 'spread': '45.74', 'groupId': 'OG001'}, {'value': '314.14', 'spread': '44.54', 'groupId': 'OG002'}, {'value': '291.81', 'spread': '45.16', 'groupId': 'OG003'}, {'value': '291.62', 'spread': '44.90', 'groupId': 'OG004'}, {'value': '291.62', 'spread': '44.90', 'groupId': 'OG005'}]}]}, {'title': 'Day 12 (n=71, 67, 69, 77, 79, 79)', 'categories': [{'measurements': [{'value': '175.52', 'spread': '57.19', 'groupId': 'OG000'}, {'value': '84.13', 'spread': '47.72', 'groupId': 'OG001'}, {'value': '212.33', 'spread': '69.65', 'groupId': 'OG002'}, {'value': '177.01', 'spread': '67.29', 'groupId': 'OG003'}, {'value': '85.46', 'spread': '60.24', 'groupId': 'OG004'}, {'value': '181.22', 'spread': '71.80', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 12', 'description': 'The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.', 'unitOfMeasure': 'P2Y12 reaction units (PRU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}, {'units': 'Participant PK Profiles', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '118', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.'}, {'id': 'OG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}, {'id': 'OG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.'}, {'id': 'OG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '43', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '35', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '62', 'groupId': 'OG002'}, {'value': '16.1', 'spread': '54', 'groupId': 'OG003'}, {'value': '36.7', 'spread': '49', 'groupId': 'OG004'}, {'value': '11.8', 'spread': '68', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to 4 hours post-dose', 'description': 'A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours \\[AUC (0-4)\\] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant PK Profiles', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All available PK sample data from all treated participants who contributed complete PK profiles.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.'}, {'id': 'OG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}, {'id': 'OG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.'}, {'id': 'OG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'OG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '79.10', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '78.75', 'spread': '9.53', 'groupId': 'OG001'}, {'value': '79.11', 'spread': '9.80', 'groupId': 'OG002'}, {'value': '76.61', 'spread': '8.07', 'groupId': 'OG003'}, {'value': '76.61', 'spread': '8.02', 'groupId': 'OG004'}, {'value': '76.61', 'spread': '8.02', 'groupId': 'OG005'}]}]}, {'title': 'Day 12 (n=71, 70, 70, 78, 79, 79)', 'categories': [{'measurements': [{'value': '57.05', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '45.54', 'spread': '11.07', 'groupId': 'OG001'}, {'value': '63.08', 'spread': '13.73', 'groupId': 'OG002'}, {'value': '56.83', 'spread': '11.62', 'groupId': 'OG003'}, {'value': '45.83', 'spread': '11.82', 'groupId': 'OG004'}, {'value': '59.09', 'spread': '13.44', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 12', 'description': 'Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.', 'unitOfMeasure': 'percentage of aggregation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5 mg Prasugrel (Elderly)', 'description': 'Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'FG001', 'title': '10 mg Prasugrel (Elderly)', 'description': 'Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.'}, {'id': 'FG002', 'title': '75 mg Clopidogrel (Elderly)', 'description': 'Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}, {'id': 'FG003', 'title': '5 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.'}, {'id': 'FG004', 'title': '10 mg Prasugrel (Non-Elderly)', 'description': 'Non-elderly participants (≥45 to \\<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.'}, {'id': 'FG005', 'title': '75 mg Clopidogrel (Non-Elderly)', 'description': 'Non-elderly participants ( ≥45 to \\<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '79'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants switched to either 10 mg prasugrel or 75 mg clopidogrel in Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'comment': 'Participants switched to either 5 mg prasugrel or 75 mg clopidogrel in Period 2.', 'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who received 75 mg clopidogrel in Period 2 received 10 mg prasugrel in Period 3', 'groupId': 'FG001', 'numSubjects': '35'}, {'comment': 'Participants who received 10 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3', 'groupId': 'FG002', 'numSubjects': '36'}, {'comment': 'Participants who received 75 mg clopidogrel in Period 2 received 5 mg prasugrel in Period 3', 'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants who received 5 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3', 'groupId': 'FG005', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Very Elderly, Drug Sequence ABC', 'description': 'Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.'}, {'id': 'BG001', 'title': 'Very Elderly; Drug Sequence ACB', 'description': 'Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.'}, {'id': 'BG002', 'title': 'Non-Elderly; Drug Sequence BAC', 'description': 'Participants (≥45 to \\<65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.'}, {'id': 'BG003', 'title': 'Non-Elderly; Drug Sequence BCA', 'description': 'Participants (≥45 to \\<65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.02', 'spread': '2.87', 'groupId': 'BG000'}, {'value': '78.74', 'spread': '3.12', 'groupId': 'BG001'}, {'value': '57.11', 'spread': '4.75', 'groupId': 'BG002'}, {'value': '55.46', 'spread': '5.53', 'groupId': 'BG003'}, {'value': '66.94', 'spread': '12.08', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '88.49', 'spread': '10.92', 'groupId': 'BG000'}, {'value': '82.30', 'spread': '10.74', 'groupId': 'BG001'}, {'value': '92.85', 'spread': '20.01', 'groupId': 'BG002'}, {'value': '93.36', 'spread': '17.32', 'groupId': 'BG003'}, {'value': '89.45', 'spread': '16.01', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tobacco Use Status at Baseline', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-27', 'studyFirstSubmitDate': '2010-04-19', 'resultsFirstSubmitDate': '2012-09-27', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-27', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period', 'timeFrame': 'Baseline, 12 days', 'description': 'Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.'}], 'secondaryOutcomes': [{'measure': 'Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy', 'timeFrame': 'Baseline, Day 12', 'description': 'Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.'}, {'measure': 'Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy', 'timeFrame': 'Baseline, Day 12', 'description': 'The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.'}, {'measure': 'Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing', 'timeFrame': 'Baseline up to 4 hours post-dose', 'description': 'A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours \\[AUC (0-4)\\] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.'}, {'measure': 'Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy', 'timeFrame': 'Baseline, Day 12', 'description': 'Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelet function'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23747759', 'type': 'DERIVED', 'citation': 'Erlinge D, Gurbel PA, James S, Lindahl TL, Svensson P, Ten Berg JM, Foley DP, Wagner H, Brown PB, Luo J, Zhou C, Moser BA, Jakubowski JA, Small DS, Winters KJ, Angiolillo DJ. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. J Am Coll Cardiol. 2013 Aug 13;62(7):577-83. doi: 10.1016/j.jacc.2013.05.023. Epub 2013 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg MD in non-elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants (Either: at least 45 years of age, but less than 65 years of age OR 75 years of age or older) with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)\n* Provision of written informed consent\n* Body weight greater than or equal to 60 kilograms (kg)\n* For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study\n\nExclusion Criteria:\n\n* Unstable coronary artery disease\n* Myocardial Infarction (MI) within the previous 30 days\n* Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days\n* History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment\n* Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation\n* Any known contraindication to treatment with an antiplatelet agent\n* Significant hypertension at the time of screening or randomisation\n* Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator\n* Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders\n* Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke\n* Prior history of thrombocytopenia or thrombocytosis\n* Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or participants receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study"}, 'identificationModule': {'nctId': 'NCT01107912', 'acronym': 'GENERATIONS', 'briefTitle': 'Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Very Elderly Versus Non-Elderly Aspirin-Treated Subjects With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': '12835'}, 'secondaryIdInfos': [{'id': 'H7T-MC-TACY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 milligrams (mg) prasugrel', 'interventionNames': ['Drug: prasugrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 mg prasugrel', 'interventionNames': ['Drug: prasugrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '75 mg clopidogrel', 'interventionNames': ['Drug: clopidogrel']}], 'interventions': [{'name': 'prasugrel', 'type': 'DRUG', 'otherNames': ['Efient', 'Effient', 'LY640315', 'CS747'], 'description': 'administered orally, daily for 12 days', 'armGroupLabels': ['10 mg prasugrel', '5 milligrams (mg) prasugrel']}, {'name': 'clopidogrel', 'type': 'DRUG', 'description': 'Administered orally, daily for 12 days', 'armGroupLabels': ['75 mg clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', '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': 30.33218, 'lon': -81.65565}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', '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': 39.29038, 'lon': -76.61219}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', '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': 39.12711, 'lon': -84.51439}}, {'zip': '9', 'city': 'Dublin', 'country': 'Ireland', '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': 53.33306, 'lon': -6.24889}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', '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': 52.02917, 'lon': 5.08056}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', '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': 55.70584, 'lon': 13.19321}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', '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': 55.60587, 'lon': 13.00073}}], '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'}}}}