Comparison of 1-month Versus 12-month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents Guided by Either Intravascular Ultrasound or Angiography in Patients With Acute Coronary Syndrome: The Prospective, Multicenter, Randomized, Placebo-controlled IVUS-ACS and ULTIMATE-DAPT Trials

NFH20190529

Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

2019-08-20

2023-10-27

2025-12-30

Active (not recruiting)

3710

Inclusion Criteria: Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month. * Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion * Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome. * ST elevation MI (STEMI) Exclusion Criteria: * Unable or unwilling to provide informed consent * Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula * Previous coronary artery bypass graft (CABG) * Any planned surgery within 90 days * Any reason why any antiplatelet therapy might need to be discontinued within 12 months * Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m\^2 * Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants) * Platelet count \< 100,000 mm\^3 * Contraindication to aspirin * Contraindication to ticagrelor * Liver cirrhosis * Women of child-bearing potential * Life expectancy \< 1 year * Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Patients will undergo 1:1 randomization (first randomization) to either IVUS-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group based on an online Clinical Research Data Management Platform. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary TVF endpoint are scheduled at 1, 4, 6, and 12 months after the index procedure.\n\nPatients will undergo 1:1 randomization (second randomization) to either SAPT which will be the treatment group or DAPT which will be the control group based on an online Clinical Research Data Management Platform. The follow-up visits for the primary superiority bleeding endpoint and non-inferiority ischemic endpoint are scheduled at 3, 5, and 11 months after the second randomization.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3710, 'type': 'ACTUAL'}}

2024-02-20