Coronary Artery Disease Clinical Trial
— SMART-CHOICE4Official title:
Comparison of Polymer-Free Cobalt-Chromium Thin Drug-Coated Stents With Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy With Conventional 12-Month Dual Antiplatelet Therapy
This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after 1-month dual antiplatelet therapy (DAPT) of aspirin plus prasugrel with 12-month DAPT of aspirin plus prasugrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. 3. Patients presenting with ACS (ST-elevation myocardial infarction [STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina) 4. Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents (DES) in native coronary artery or graft Exclusion Criteria: 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, clopidogrel, prasugrel, or major components of drug-eluting stents 3. Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment) 4. Patients who need chronic anti-coagulation therapy 5. Patients with active pathological bleeding 6. Pregnant or lactating women Additional Exclusion Criteria for Antiplatelet Comparison Study: 1. Patients with history of stroke or transient ischemic attack 2. Patients 75 years of age or older 3. Patients weighing less than 60 kg |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stent Comparison Study: target-lesion failure (TLF) | a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods | 1 year | |
Primary | Antiplatelet Comparison Study: net adverse clinical events (NACE) | a composite of major adverse cardiac and cerebrovascular events (MACCE) and clinically relevant bleeding | 1 year | |
Secondary | Stent Comparison Study: TLF | a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods | 3 years | |
Secondary | Stent Comparison Study: target-vessel failure | a composite of cardiac death, target vessel-MI, or clinically indicated target-vessel revascularization by percutaneous or surgical methods | 1 and 3 years | |
Secondary | Stent Comparison Study: cardiac death | cardiac death | 1 and 3 years | |
Secondary | Stent Comparison Study: target-vessel myocardial infarction (MI) | target-vessel MI | 1 and 3 years | |
Secondary | Stent Comparison Study: clinically indicated TLR | clinically indicated TLR | 1 and 3 years | |
Secondary | Stent Comparison Study: stent thrombosis | definite or probable by Academic Research Consortium [ARC] definition | 1 and 3 years | |
Secondary | Stent Comparison Study: clinically indicated target-vessel revascularization (TVR) | clinically indicated target-vessel revascularization (TVR) | 1 and 3 years | |
Secondary | Stent Comparison Study: cardiac death or MI | cardiac death or MI | 1 and 3 years | |
Secondary | Stent Comparison Study: cardiac death, MI, or stent thrombosis | cardiac death, MI, or stent thrombosis | 1 and 3 years | |
Secondary | Stent Comparison Study: all-cause death | all-cause death | 1 and 3 years | |
Secondary | Stent Comparison Study: MI | MI | 1 and 3 years | |
Secondary | Stent Comparison Study: all-cause death or MI | all-cause death or MI | 1 and 3 years | |
Secondary | Stent Comparison Study: any revascularization | any revascularization | 1 and 3 years | |
Secondary | Stent Comparison Study: restricted mean survival time for the TLF | restricted mean survival time for the TLF | 1 and 3 years | |
Secondary | Antiplatelet Comparison Study: MACCE | a composite of all-cause death, MI, and stroke | 1 year | |
Secondary | Antiplatelet Comparison Study: clinically relevant bleeding | bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding | 1 year | |
Secondary | Antiplatelet Comparison Study: all-cause death | all-cause death | 1 year | |
Secondary | Antiplatelet Comparison Study: MI | MI | 1 year | |
Secondary | Antiplatelet Comparison Study: stroke | stroke | 1 year | |
Secondary | Antiplatelet Comparison Study: cardiac death | cardiac death | 1 year | |
Secondary | Antiplatelet Comparison Study: stent thrombosis | definite or probable by ARC definition | 1 year | |
Secondary | Antiplatelet Comparison Study: all-cause death or MI | all-cause death or MI | 1 year | |
Secondary | Antiplatelet Comparison Study: cardiac death or MI | cardiac death or MI | 1 year | |
Secondary | Antiplatelet Comparison Study: cardiac death, MI, or stent thrombosis | cardiac death, MI, or stent thrombosis | 1 year | |
Secondary | Antiplatelet Comparison Study: BARC type 3 or 5 bleeding | BARC type 3 or 5 bleeding | 1 year | |
Secondary | Antiplatelet Comparison Study: restricted mean survival time for the NACE | restricted mean survival time for the NACE | 1 year |
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