Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-02 @ 1:24 PM
Study NCT ID:
NCT03338335
Status:
UNKNOWN
Last Update Posted:
2018-02-22
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration
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': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary ischemic endpoint', 'timeFrame': '2 years', 'description': 'major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis'}, {'measure': 'primary bleeding endpoints', 'timeFrame': '2 years', 'description': 'major bleeding events'}], 'secondaryOutcomes': [{'measure': 'all-cause death', 'timeFrame': '2 years'}, {'measure': 'cardiac death', 'timeFrame': '2 years'}, {'measure': 'non-cardiac death', 'timeFrame': '2 years'}, {'measure': 'any myocardial infarction', 'timeFrame': '2 years'}, {'measure': 'any stroke', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Dual Antiplatelet Therapy']}, 'referencesModule': {'references': [{'pmid': '30597509', 'type': 'DERIVED', 'citation': 'Kang J, Park KW, Palmerini T, Stone GW, Lee MS, Colombo A, Chieffo A, Feres F, Abizaid A, Bhatt DL, Valgimigli M, Hong MK, Jang Y, Gilard M, Morice MC, Park DW, Park SJ, Jeong YH, Park J, Koo BK, Kim HS. Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. Thromb Haemost. 2019 Jan;119(1):149-162. doi: 10.1055/s-0038-1676545. Epub 2018 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'individual participant data (IPD) meta-analysis of randomized controlled trials designed to investigate the efficacy and safety of shorter duration of DAPT with a longer duration DAPT in patients with ischemic heart diseases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy'}, 'identificationModule': {'nctId': 'NCT03338335', 'briefTitle': 'Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ethnic Differences in Ischemia/Bleeding Risk Tradeoff During Antiplatelet Therapy After Drug-eluting Stent Implantation', 'orgStudyIdInfo': {'id': 'DAPT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prolonged DAPT', 'type': 'DRUG', 'description': 'Dual antiplatelet therapy will be prescribed for more than 12 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This will be decided after the present analysis is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}