Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 9:33 AM
Study NCT ID:
NCT01069003
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2010-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sidney.a.cohen@medtonic.com', 'phone': '707-591-7277', 'title': 'Sidney Cohen, Sr. Clinical Medical Advisor', 'organization': 'Medtronic'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Arm', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)', 'otherNumAtRisk': 399, 'otherNumAffected': 0, 'seriousNumAtRisk': 399, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)', 'otherNumAtRisk': 412, 'otherNumAffected': 0, 'seriousNumAtRisk': 412, 'seriousNumAffected': 111}, {'id': 'EG002', 'title': 'Surveillance Arm', 'description': 'Non randomized subjects followed through 24 months', 'otherNumAtRisk': 1451, 'otherNumAffected': 90, 'seriousNumAtRisk': 1451, 'seriousNumAffected': 664}], 'otherEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 96, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 59, 'numAffected': 55}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 41, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 40, 'numAffected': 39}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac Enzymes Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 53, 'numAffected': 39}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 128, 'numAffected': 97}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 33, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 51, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'In-Stent Coronary Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Retroperitoneal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Therapeutic Embolisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thrombosis In Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '1451', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG002', 'title': 'Surveillance Arm', 'description': 'Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}, {'value': '16.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '1451', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm', 'description': 'Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG002', 'title': 'Surveillance Arm', 'description': 'Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)', 'description': 'All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)\n\nDefinite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers\n\nProbable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '1451', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'OG002', 'title': 'Surveillance Arm', 'description': 'Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'FG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'FG002', 'title': 'Surveillance Arm', 'description': 'Non randomized subjects followed for total of 24 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '399'}, {'groupId': 'FG001', 'numSubjects': '412'}, {'groupId': 'FG002', 'numSubjects': '1451'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '358'}, {'groupId': 'FG002', 'numSubjects': '976'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '475'}]}]}], 'preAssignmentDetails': 'Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '1451', 'groupId': 'BG002'}, {'value': '2262', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Arm', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).\n\nPlacebo (12-Month Arm): Placebo\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'BG001', 'title': 'Thienopyridine Therapy', 'description': 'Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).\n\nPrasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg\n\nASA: 75 mg - 325 mg Aspirin(ASA)'}, {'id': 'BG002', 'title': 'Surveillance Arm', 'description': 'Non randomized subjects followed for total of 24 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '63.3', 'spread': '10.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}, {'value': '687', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '1002', 'groupId': 'BG002'}, {'value': '1575', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '372', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '1409', 'groupId': 'BG002'}, {'value': '2166', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The intent to treat arm contains non randomized subjects followed through 24 months'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-11', 'studyFirstSubmitDate': '2010-02-12', 'resultsFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-11', 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)'}, {'measure': 'Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)', 'description': 'All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)\n\nDefinite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers\n\nProbable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause'}, {'measure': 'Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects', 'timeFrame': 'Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Disease', 'Cardiovascular Disease', 'Platelet Aggregation Inhibitors', 'Dual Antiplatelet Therapy', 'Clopidogrel', 'Prasugrel', 'Vascular Disease', 'Myocardial Ischemia'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25703885', 'type': 'DERIVED', 'citation': 'Cutlip DE, Kereiakes DJ, Mauri L, Stoler R, Dauerman HL; EDUCATE Investigators. Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy. JACC Cardiovasc Interv. 2015 Mar;8(3):404-410. doi: 10.1016/j.jcin.2014.10.017. Epub 2015 Feb 18.'}], 'seeAlsoLinks': [{'url': 'http://www.daptstudy.org/', 'label': 'Native DAPT Study Web Site'}, {'url': 'http://www.hcri.harvard.edu/', 'label': 'Harvard Clinical Research Institute'}]}, 'descriptionModule': {'briefSummary': 'EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.', 'detailedDescription': 'To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'ENROLLMENT INCLUSION CRITERIA\n\n* Patient is older than 18 years.\n* The patient or patient\'s legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Subject Informed Consent Form".\n* Patients undergoing percutaneous intervention with Endeavor stent deployment (or has within 24 hours).\n* The patient is willing and able to cooperate with study procedures and required follow up visits.\n\nENROLLMENT EXCLUSION CRITERIA\n\n* Index procedure stent placement with stent diameter \\< 2.5 mm or \\> 3.5 mm.\n* Pregnant women.\n* Current medical condition with a life expectancy of less than 3 years.\n* The patient is currently participating in another investigational device or drug study that clinically interferes with the EDUCATE Study. The patient may only be enrolled in the EDUCATE Study once.\n* Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.\n* Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.\n* Patients treated with any stent other than the Endeavor stent during the index procedure.\n\nRANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS\n\n* Subject is "12 Month Clear".\n* Subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization.\n\nRANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS\n\n* Pregnant women.\n* Subject switched thienopyridine type or dose within 6 months prior to randomization.\n* Planned surgery necessitating discontinuation of antiplatelet therapy within the 18 months following randomization.\n* Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.\n* Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.\n* Current medical condition with a life expectancy of less than 3 years.\n* Subjects on warfarin or similar anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT01069003', 'acronym': 'EDUCATE', 'briefTitle': 'EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Vascular'}, 'officialTitle': 'EDUCATE: a Prospective, Multi-center Study Designed to Collect Real-world Safety and Clinical Outcomes in Subjects Receiving One or More Endeavor Zotarolimus-Eluting Stents and Either Clopidogrel and Aspirin or Prasugrel and Aspirin as Part of a Dual Antiplatelet Therapy (DAPT) Drug Regimen', 'orgStudyIdInfo': {'id': 'IP114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.', 'interventionNames': ['Drug: Placebo Arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thienopyridine Therapy', 'description': 'Subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.', 'interventionNames': ['Drug: Thienopyridine Therapy']}, {'type': 'OTHER', 'label': 'Surveillance Arm', 'description': 'Non randomized subjects followed through 24 months', 'interventionNames': ['Device: Surveillance Arm']}], 'interventions': [{'name': 'Placebo Arm', 'type': 'DRUG', 'description': 'Placebo and ASA (75 mg - 325 mg)', 'armGroupLabels': ['Placebo Arm']}, {'name': 'Thienopyridine Therapy', 'type': 'DRUG', 'description': 'Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)', 'armGroupLabels': ['Thienopyridine Therapy']}, {'name': 'Surveillance Arm', 'type': 'DEVICE', 'description': 'Non randomized arm to understand clinical outcomes in a commercial setting', 'armGroupLabels': ['Surveillance Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health Medical Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}], 'overallOfficials': [{'name': 'Donald Cutlip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'Harold Dauerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fletcher Allen Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}