Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-04 @ 5:35 PM
Study NCT ID:
NCT02837003
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C446540', 'term': 'thienopyridine'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-31', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).', 'timeFrame': '12-month'}], 'secondaryOutcomes': [{'measure': 'Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).', 'timeFrame': '3-month'}, {'measure': 'Major adverse cardiac event', 'timeFrame': '3-month'}, {'measure': 'Major adverse cardiac event', 'timeFrame': '12-month'}, {'measure': 'All cause death', 'timeFrame': '3-month'}, {'measure': 'All cause death', 'timeFrame': '12-month'}, {'measure': 'Cardiac death', 'timeFrame': '3-month'}, {'measure': 'Cardiac death', 'timeFrame': '12-month'}, {'measure': 'Myocardial infarction', 'timeFrame': '3-month'}, {'measure': 'Myocardial infarction', 'timeFrame': '12-month'}, {'measure': 'Stroke (ischemic and hemorrhagic)', 'timeFrame': '3-month'}, {'measure': 'Stroke (ischemic and hemorrhagic)', 'timeFrame': '12-month'}, {'measure': 'Target lesion revascularization', 'timeFrame': '3-month'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12-month'}, {'measure': 'Target vessel revascularization', 'timeFrame': '3-month'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12-month'}, {'measure': 'Readmission related to angina', 'timeFrame': '3-month'}, {'measure': 'Readmission related to angina', 'timeFrame': '12-month'}, {'measure': 'Stent thrombosis', 'timeFrame': '3-month'}, {'measure': 'Stent thrombosis (ARC definition)', 'timeFrame': '12-month'}, {'measure': 'Bleeding complications (BARC definition)', 'timeFrame': '3-month'}, {'measure': 'Bleeding complications (BARC definition)', 'timeFrame': '12-month'}, {'measure': 'Comparison of event rate by the type of antiplatelet agent', 'timeFrame': '12-month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug-Eluting Stent'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).\n\nAdditionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.\n* Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.\n* Patients who have provided written informed consent.\n\nExclusion Criteria:\n\n* Patients previously experienced stent thrombosis.\n* Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.\n* Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.'}, 'identificationModule': {'nctId': 'NCT02837003', 'acronym': 'MODEL U-SES', 'briefTitle': '3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Teikyo University'}, 'officialTitle': '3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation', 'orgStudyIdInfo': {'id': 'MODEL U-SES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental: Aspirin', 'description': 'Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.', 'interventionNames': ['Drug: Aspirin']}, {'label': 'Experimental: Thienopyridine', 'description': 'Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.', 'interventionNames': ['Drug: Thienopyridine']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': "Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.", 'armGroupLabels': ['Experimental: Aspirin']}, {'name': 'Thienopyridine', 'type': 'DRUG', 'description': "Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.", 'armGroupLabels': ['Experimental: Thienopyridine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '173-8606', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ken Kozuma, MD, PhD', 'role': 'CONTACT', 'email': 'PXE00364@nifty.com', 'phone': '+81-3-3964-1211'}], 'facility': 'Teikyo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Ken Kozuma, MD, PhD', 'role': 'CONTACT', 'email': 'PXE00364@nifty.com', 'phone': '+81-3-3964-1211'}], 'overallOfficials': [{'name': 'Ken Kozuma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teikyo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teikyo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}