Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 5:55 AM
Study NCT ID:
NCT01735305
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14032}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac and cerebral events', 'timeFrame': '12month', 'description': 'a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke'}], 'secondaryOutcomes': [{'measure': 'all cause death', 'timeFrame': '12month'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 month', 'description': 'by BARC definition'}, {'measure': 'rehospitalization', 'timeFrame': '12 month', 'description': 'any rehospitalization for cardiac or noncardiac reasons'}, {'measure': 'any bleeding events', 'timeFrame': '12 month', 'description': 'by BARC definition'}, {'measure': 'recurrent angina', 'timeFrame': '12 month'}, {'measure': 'myocardial infarction', 'timeFrame': '12 months'}, {'measure': 'stroke', 'timeFrame': '12 months'}, {'measure': 'any revascularization', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'antiplatelet therapy'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '32418142', 'type': 'DERIVED', 'citation': 'Ma S, Jiang Z, Qiu M, Li Z, Bian L, Li Y, Han Y. Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study. Adv Ther. 2020 Jul;37(7):3150-3161. doi: 10.1007/s12325-020-01376-0. Epub 2020 May 16.'}, {'pmid': '30334527', 'type': 'DERIVED', 'citation': 'Feng YQ, He XY, Song FE, Chen JY. Association between Contrast Media Volume and 1-Year Clinical Outcomes in Patients Undergoing Coronary Angiography. Chin Med J (Engl). 2018 Oct 20;131(20):2424-2432. doi: 10.4103/0366-6999.243563.'}]}, 'descriptionModule': {'briefSummary': 'Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years old who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were physician discretion.', 'detailedDescription': 'Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were at physician discretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient of coronary heart disease receiving any antiplatelet therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Clinical diagnosis of coronary heart disease\n2. Age \\>= 18 years old\n3. receiving any antiplatelet agents\n4. Informed written consent signed\n\nExclusion Criteria:\n\n1. With severe disease and life expectancy for 6 months or less\n2. Difficult to attain follow-up situations judged by researchers (travel, speech or mental disorder, etc.)\n3. Taking part in an interventional clinical research'}, 'identificationModule': {'nctId': 'NCT01735305', 'acronym': 'OPT-CAD', 'briefTitle': 'Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': 'Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'SYNH-20121113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antiplatelet therapy', 'description': 'patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The first affiliated hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The 304th Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The 306th of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Luhe teaching hospital of the Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "The People's Hospital of Beijing University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Yanshan 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{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Baiyun district hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou military region general hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Panyu district central hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Liwan District People's Hospital of Guangzhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The first hospital of Guangzhou', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 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'facility': "The People's Hospital of Tangxian", 'geoPoint': {'lat': 38.74669, 'lon': 114.98009}}, {'city': 'Rongcheng', 'state': 'Hebei', 'country': 'China', 'facility': "The people's hospital of Rongcheng", 'geoPoint': {'lat': 39.053, 'lon': 115.85989}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Bethune International Peace Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Zhangjiakou', 'state': 'Hebei', 'country': 'China', 'facility': 'The 251st of PLA', 'geoPoint': {'lat': 40.78341, 'lon': 114.87139}}, {'city': 'Daqing', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Daqing oil field hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Heilongjiang provincial hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The 211st of PLA', 'geoPoint': {'lat': 45.75, 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'facility': 'The 463rd Hospital of PLA', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The first people's hospital of Shenyang", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The Forth affiliated hospital of Liaoning University of Traditional Chinese Medicine', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Shenyang Medical College', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Shenyang Medical 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'Tianjin Municipality', 'country': 'China', 'facility': 'The 254th of PLA', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Lhasa', 'state': 'Tibet', 'country': 'China', 'facility': 'Xizang military general hospital', 'geoPoint': {'lat': 29.65, 'lon': 91.1}}, {'city': 'Huiyuan', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The 11st of PLA', 'geoPoint': {'lat': 43.95694, 'lon': 80.85028}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'General hospital of Wulumuqi', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The Chest Hospital of Xinjiang Uyghur Autonomous Region', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Yisa', 'state': 'Yunnan', 'country': 'China', 'facility': 'The 4th public hospital of Honghe', 'geoPoint': {'lat': 23.33231, 'lon': 102.44711}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou first people's hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yaling Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Military Region General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Han Yaling', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}