Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 1:11 PM
Study NCT ID:
NCT00356135
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2006-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Sponsor:
Organization:
Raw JSON
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Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.', 'otherNumAtRisk': 47, 'otherNumAffected': 16, 'seriousNumAtRisk': 47, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.', 'otherNumAtRisk': 48, 'otherNumAffected': 25, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.', 'otherNumAtRisk': 44, 'otherNumAffected': 11, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyshidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'In-stent coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'OG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'OG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '41.0', 'spread': '2.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.91', 'ciLowerLimit': '-19.10', 'ciUpperLimit': '-8.73', 'estimateComment': 'Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.98', 'ciLowerLimit': '-19.26', 'ciUpperLimit': '-8.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 week after first dose of randomized study drug', 'description': 'Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).', 'unitOfMeasure': 'percent maximum platelet aggregation (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.'}, {'type': 'SECONDARY', 'title': 'Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'OG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'OG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'classes': [{'title': '2 Hour (20 uM ADP)', 'categories': [{'measurements': [{'value': '49.46', 'spread': '21.243', 'groupId': 'OG000', 'lowerLimit': '-8.22', 'upperLimit': '3.35'}, {'value': '48.07', 'spread': '17.728', 'groupId': 'OG001', 'lowerLimit': '-29.30', 'upperLimit': '-17.51'}, {'value': '26.65', 'spread': '10.875', 'groupId': 'OG002'}]}]}, {'title': '24 Hour (20 uM ADP)', 'categories': [{'measurements': [{'value': '52.29', 'spread': '16.511', 'groupId': 'OG000', 'lowerLimit': '-8.82', 'upperLimit': '0.32'}, {'value': '53.80', 'spread': '14.504', 'groupId': 'OG001', 'lowerLimit': '-33.20', 'upperLimit': '-23.94'}, {'value': '27.36', 'spread': '10.812', 'groupId': 'OG002'}]}]}, {'title': '1 Week (20 uM ADP)', 'categories': [{'measurements': [{'value': '42.95', 'spread': '14.963', 'groupId': 'OG000', 'lowerLimit': '-19.96', 'upperLimit': '-9.65'}, {'value': '53.80', 'spread': '14.878', 'groupId': 'OG001', 'lowerLimit': '-19.87', 'upperLimit': '-9.32'}, {'value': '40.64', 'spread': '10.182', 'groupId': 'OG002'}]}]}, {'title': '2 Week (20 uM ADP)', 'categories': [{'measurements': [{'value': '40.84', 'spread': '13.359', 'groupId': 'OG000', 'lowerLimit': '-20.30', 'upperLimit': '-9.22'}, {'value': '52.25', 'spread': '16.856', 'groupId': 'OG001', 'lowerLimit': '-20.59', 'upperLimit': '-9.22'}, {'value': '38.61', 'spread': '13.373', 'groupId': 'OG002'}]}]}, {'title': '2 Hour (5 uM ADP)', 'categories': [{'measurements': [{'value': '37.87', 'spread': '16.547', 'groupId': 'OG000', 'lowerLimit': '-5.85', 'upperLimit': '3.14'}, {'value': '37.25', 'spread': '12.579', 'groupId': 'OG001', 'lowerLimit': '-21.55', 'upperLimit': '-12.37'}, {'value': '19.97', 'spread': '11.263', 'groupId': 'OG002'}]}]}, {'title': '24 Hour (5 uM ADP)', 'categories': [{'measurements': [{'value': '38.84', 'spread': '14.841', 'groupId': 'OG000', 'lowerLimit': '-8.58', 'upperLimit': '0.42'}, {'value': '40.88', 'spread': '14.540', 'groupId': 'OG001', 'lowerLimit': '-24.81', 'upperLimit': '-15.64'}, {'value': '20.94', 'spread': '11.476', 'groupId': 'OG002'}]}]}, {'title': '1 Week (5 uM ADP)', 'categories': [{'measurements': [{'value': '32.44', 'spread': '11.739', 'groupId': 'OG000', 'lowerLimit': '-17.21', 'upperLimit': '-7.50'}, {'value': '41.94', 'spread': '14.436', 'groupId': 'OG001', 'lowerLimit': '-15.79', 'upperLimit': '-5.79'}, {'value': '31.45', 'spread': '11.446', 'groupId': 'OG002'}]}]}, {'title': '2 Week (5 uM ADP)', 'categories': [{'measurements': [{'value': '30.18', 'spread': '11.444', 'groupId': 'OG000', 'lowerLimit': '-17.41', 'upperLimit': '-7.72'}, {'value': '41.05', 'spread': '13.570', 'groupId': 'OG001', 'lowerLimit': '-16.80', 'upperLimit': '-6.82'}, {'value': '28.64', 'spread': '13.534', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-8.22', 'ciUpperLimit': '3.35', 'pValueComment': 'P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23', 'ciLowerLimit': '-29.30', 'ciUpperLimit': '-17.51', 'pValueComment': 'P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-8.82', 'ciUpperLimit': '0.32', 'pValueComment': 'P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29', 'ciLowerLimit': '-33.20', 'ciUpperLimit': '-23.94', 'pValueComment': 'P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'groupDescription': 'Comparison of MPA to 20 uM ADP at 24 hours', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-19.96', 'ciUpperLimit': '-9.65', 'pValueComment': 'P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-19.87', 'ciUpperLimit': '-9.32', 'pValueComment': 'P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-20.30', 'ciUpperLimit': '-9.22', 'pValueComment': 'P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-20.59', 'ciUpperLimit': '-9.22', 'pValueComment': 'P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.85', 'ciUpperLimit': '3.14', 'pValueComment': 'P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17', 'ciLowerLimit': '-21.55', 'ciUpperLimit': '-12.37', 'pValueComment': 'P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-8.58', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20', 'ciLowerLimit': '-24.81', 'ciUpperLimit': '-15.64', 'pValueComment': 'P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-17.21', 'ciUpperLimit': '-7.50', 'pValueComment': 'P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-15.79', 'ciUpperLimit': '-5.79', 'pValueComment': 'P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13', 'ciLowerLimit': '-17.41', 'ciUpperLimit': '-7.72', 'pValueComment': 'P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-16.80', 'ciUpperLimit': '-6.82', 'pValueComment': 'P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug', 'description': 'Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).', 'unitOfMeasure': 'percent maximum platelet aggregation (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.'}, {'type': 'SECONDARY', 'title': 'Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clopidogrel Use', 'description': 'Patients with clopidogrel use at the time of qualifying ACS event.'}, {'id': 'OG001', 'title': 'No Clopidogrel Use', 'description': 'Patients with no clopidogrel use at the time of qualifying ACS event.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.73', 'spread': '18.729', 'groupId': 'OG000'}, {'value': '55.53', 'spread': '14.356', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1824', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1101', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.', 'statisticalMethod': 'F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End of 14 day open label', 'description': 'Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.', 'unitOfMeasure': 'percent maximum platelet aggregation (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.'}, {'type': 'SECONDARY', 'title': 'Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'OG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'OG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'classes': [{'title': '2 Hour (20 uM ADP)', 'categories': [{'measurements': [{'value': '32.06', 'spread': '24.462', 'groupId': 'OG000', 'lowerLimit': '-9.50', 'upperLimit': '3.37'}, {'value': '28.21', 'spread': '21.792', 'groupId': 'OG001', 'lowerLimit': '-33.40', 'upperLimit': '-20.33'}, {'value': '5.10', 'spread': '7.814', 'groupId': 'OG002'}]}]}, {'title': '24 Hour (20 uM ADP)', 'categories': [{'measurements': [{'value': '32.97', 'spread': '21.858', 'groupId': 'OG000', 'lowerLimit': '-13.04', 'upperLimit': '-1.60'}, {'value': '35.16', 'spread': '19.379', 'groupId': 'OG001', 'lowerLimit': '-39.99', 'upperLimit': '-28.42'}, {'value': '4.70', 'spread': '5.688', 'groupId': 'OG002'}]}]}, {'title': '1 Week (20 uM ADP)', 'categories': [{'measurements': [{'value': '22.92', 'spread': '17.961', 'groupId': 'OG000', 'lowerLimit': '-25.58', 'upperLimit': '-11.09'}, {'value': '34.45', 'spread': '21.752', 'groupId': 'OG001', 'lowerLimit': '-27.09', 'upperLimit': '-12.26'}, {'value': '17.94', 'spread': '12.961', 'groupId': 'OG002'}]}]}, {'title': '2 Week (20 uM ADP)', 'categories': [{'measurements': [{'value': '18.89', 'spread': '14.401', 'groupId': 'OG000', 'lowerLimit': '-28.42', 'upperLimit': '-14.77'}, {'value': '34.56', 'spread': '19.515', 'groupId': 'OG001', 'lowerLimit': '-29.61', 'upperLimit': '-15.63'}, {'value': '15.17', 'spread': '15.127', 'groupId': 'OG002'}]}]}, {'title': '2 Hour (5 uM ADP)', 'categories': [{'measurements': [{'value': '18.83', 'spread': '17.574', 'groupId': 'OG000', 'lowerLimit': '-3.11', 'upperLimit': '6.38'}, {'value': '14.84', 'spread': '12.767', 'groupId': 'OG001', 'lowerLimit': '-15.92', 'upperLimit': '-6.24'}, {'value': '4.17', 'spread': '4.878', 'groupId': 'OG002'}]}]}, {'title': '24 Hour (5 uM ADP)', 'categories': [{'measurements': [{'value': '19.18', 'spread': '16.448', 'groupId': 'OG000', 'lowerLimit': '-8.31', 'upperLimit': '1.74'}, {'value': '19.66', 'spread': '14.672', 'groupId': 'OG001', 'lowerLimit': '-20.98', 'upperLimit': '-10.75'}, {'value': '4.45', 'spread': '4.545', 'groupId': 'OG002'}]}]}, {'title': '1 Week (5 uM ADP)', 'categories': [{'measurements': [{'value': '11.11', 'spread': '10.325', 'groupId': 'OG000', 'lowerLimit': '-18.81', 'upperLimit': '-7.32'}, {'value': '21.57', 'spread': '18.829', 'groupId': 'OG001', 'lowerLimit': '-17.91', 'upperLimit': '-6.09'}, {'value': '9.94', 'spread': '10.370', 'groupId': 'OG002'}]}]}, {'title': '2 Week (5 uM ADP)', 'categories': [{'measurements': [{'value': '10.03', 'spread': '9.247', 'groupId': 'OG000', 'lowerLimit': '-15.64', 'upperLimit': '-6.32'}, {'value': '19.28', 'spread': '14.824', 'groupId': 'OG001', 'lowerLimit': '-14.67', 'upperLimit': '-5.09'}, {'value': '9.43', 'spread': '8.621', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-9.50', 'ciUpperLimit': '3.37', 'pValueComment': 'P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27', 'ciLowerLimit': '-33.40', 'ciUpperLimit': '-20.33', 'pValueComment': 'P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-13.04', 'ciUpperLimit': '-1.60', 'pValueComment': 'P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34', 'ciLowerLimit': '-39.99', 'ciUpperLimit': '-28.42', 'pValueComment': 'P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18', 'ciLowerLimit': '-25.58', 'ciUpperLimit': '-11.09', 'pValueComment': 'P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20', 'ciLowerLimit': '-27.09', 'ciUpperLimit': '-12.26', 'pValueComment': 'P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22', 'ciLowerLimit': '-28.42', 'ciUpperLimit': '-14.77', 'pValueComment': 'P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23', 'ciLowerLimit': '-29.61', 'ciUpperLimit': '-15.63', 'pValueComment': 'P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4954', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '6.38', 'pValueComment': 'P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-15.92', 'ciUpperLimit': '-6.24', 'pValueComment': 'P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-8.31', 'ciUpperLimit': '1.74', 'pValueComment': 'P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16', 'ciLowerLimit': '-20.98', 'ciUpperLimit': '-10.75', 'pValueComment': 'P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13', 'ciLowerLimit': '-18.81', 'ciUpperLimit': '-7.32', 'pValueComment': 'P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-17.91', 'ciUpperLimit': '-6.09', 'pValueComment': 'P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-15.64', 'ciUpperLimit': '-6.32', 'pValueComment': 'P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.9', 'ciLowerLimit': '-14.67', 'ciUpperLimit': '-5.09', 'pValueComment': 'P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.', 'estimateComment': 'Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug', 'description': 'Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).', 'unitOfMeasure': 'percent residual platelet aggregation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'OG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'OG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'classes': [{'title': 'MPA (20 uM ADP) at 1 week', 'categories': [{'measurements': [{'value': '0.564', 'groupId': 'OG000'}, {'value': '0.426', 'groupId': 'OG001'}, {'value': '0.439', 'groupId': 'OG002'}]}]}, {'title': 'RPA (20 uM ADP) at 1 week', 'categories': [{'measurements': [{'value': '0.640', 'groupId': 'OG000'}, {'value': '0.425', 'groupId': 'OG001'}, {'value': '0.547', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value for MPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P-value for RPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0150', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for MPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0152', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for RPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0153', 'groupIds': ['OG002'], 'ciPctValue': '95', 'pValueComment': 'P-value for MPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0018', 'groupIds': ['OG002'], 'ciPctValue': '95', 'pValueComment': 'P-value for RPA (20 uM ADP) at 1 week.', 'statisticalMethod': 'Pearson Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week after randomized study drug', 'description': 'Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'OG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'OG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'classes': [{'title': 'Any Bleeding at Any Time During Randomized Period', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Any Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Insignificant Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Minor Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Major Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24: Any Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24: Insignificant Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24: Minor Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24: Major Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: Any Bleeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: Insignificant Bleeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: Minor Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 7: Major Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Any Bleeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Insignificant Bleeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Minor Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 14: Major Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug', 'description': 'Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but \\<5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prasgurel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'FG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'FG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '30-330 days after acute coronary syndrome event, patients participated in 2 week open-label clopidogrel phase. Patients were then randomized to either 22-26 hour loading doses of: 60-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, then continued 2-week maintenance phase of 10-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Prasugrel 10/10 mg', 'description': 'Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'BG001', 'title': 'Clopidogrel 75/75 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.'}, {'id': 'BG002', 'title': 'Prasugrel 60/10 mg', 'description': 'Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '8.18', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '8.93', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '9.16', 'groupId': 'BG002'}, {'value': '57.7', 'spread': '8.73', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'breakdown of participants by race/ethnicity', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2006-07-21', 'resultsFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2006-07-21', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-22', 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)', 'timeFrame': '1 week after first dose of randomized study drug', 'description': 'Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).'}], 'secondaryOutcomes': [{'measure': 'Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks', 'timeFrame': '2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug', 'description': 'Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).'}, {'measure': 'Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event', 'timeFrame': 'End of 14 day open label', 'description': 'Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.'}, {'measure': 'Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks', 'timeFrame': '2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug', 'description': 'Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).'}, {'measure': 'Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week', 'timeFrame': '1 week after randomized study drug', 'description': 'Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.'}, {'measure': 'Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria', 'timeFrame': 'End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug', 'description': 'Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but \\<5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.'}]}, 'conditionsModule': {'conditions': ['Coronary Arteriosclerosis', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '20846599', 'type': 'RESULT', 'citation': 'Angiolillo DJ, Saucedo JF, Deraad R, Frelinger AL, Gurbel PA, Costigan TM, Jakubowski JA, Ojeh CK, Effron MB; SWAP Investigators. Increased platelet inhibition after switching from maintenance clopidogrel to prasugrel in patients with acute coronary syndromes: results of the SWAP (SWitching Anti Platelet) study. J Am Coll Cardiol. 2010 Sep 21;56(13):1017-23. doi: 10.1016/j.jacc.2010.02.072.'}, {'pmid': '23223867', 'type': 'DERIVED', 'citation': 'Saucedo JF, Angiolillo DJ, DeRaad R, Frelinger AL 3rd, Gurbel PA, Costigan TM, Jakubowski JA, Ojeh CK, Duvvuru S, Effron MB; SWAP Investigators. Decrease in high on-treatment platelet reactivity (HPR) prevalence on switching from clopidogrel to prasugrel: insights from the switching anti-platelet (SWAP) study. Thromb Haemost. 2013 Feb;109(2):347-55. doi: 10.1160/TH12-06-0378. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel.\n* Are of a legal age (and at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent before entering the study.\n\nExclusion Criteria:\n\n* Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.\n* Have any form of coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) planned to occur during the study (from signing consent through the final visit).\n* Have undergone CABG or PCI within 30 days of entry into the study.\n* Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.\n* Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.\n* Have any of the following: history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA), have a body weight less than 60 kilograms (kg).'}, 'identificationModule': {'nctId': 'NCT00356135', 'acronym': 'SWAP', 'briefTitle': 'Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus Clopidogrel in Subjects With Acute Coronary Syndrome Who Are Receiving Clopidogrel', 'orgStudyIdInfo': {'id': '10631'}, 'secondaryIdInfos': [{'id': 'H7T-MC-TABM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prasugrel 10/10 mg', 'description': 'Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.', 'interventionNames': ['Drug: prasugrel 10 mg', 'Drug: clopidogrel', 'Drug: prasugrel placebo', 'Drug: clopidogrel placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Clopidogrel 75/75 mg', 'description': 'Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.', 'interventionNames': ['Drug: clopidogrel', 'Drug: prasugrel placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel 60/10 mg', 'description': 'Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.', 'interventionNames': ['Drug: prasugrel 10 mg', 'Drug: clopidogrel', 'Drug: prasugrel 60 mg', 'Drug: clopidogrel placebo']}], 'interventions': [{'name': 'prasugrel 10 mg', 'type': 'DRUG', 'otherNames': ['LY640315', 'Effient', 'Efient'], 'description': '10 mg tablet taken orally', 'armGroupLabels': ['Prasugrel 10/10 mg', 'Prasugrel 60/10 mg']}, {'name': 'clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix', 'Clopilet', 'Clavix'], 'description': '75 mg tablet taken orally', 'armGroupLabels': ['Clopidogrel 75/75 mg', 'Prasugrel 10/10 mg', 'Prasugrel 60/10 mg']}, {'name': 'prasugrel placebo', 'type': 'DRUG', 'description': 'oral, as blinding mechanism.', 'armGroupLabels': ['Clopidogrel 75/75 mg', 'Prasugrel 10/10 mg']}, {'name': 'prasugrel 60 mg', 'type': 'DRUG', 'otherNames': ['LY640315', 'Effient', 'Efient'], 'description': '60 mg (six 10-mg tablets) taken orally', 'armGroupLabels': ['Prasugrel 60/10 mg']}, {'name': 'clopidogrel placebo', 'type': 'DRUG', 'description': 'oral, as blinding mechanism', 'armGroupLabels': ['Prasugrel 10/10 mg', 'Prasugrel 60/10 mg']}]}, '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) Monday-Friday from 9:00 AM to 5:00 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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '45219', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', '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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 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', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}