Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- A composite of death, myocardial infarction, or cerebrovascular events
研究概览
简要总结
To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.
详细描述
This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 20 years of age.
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Patients undergoing successful PCI
排除标准
- •Hemodynamic instability or cardiogenic shock
- •Active bleeding
- •Known hypersensitivity or contraindication to study medications
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- •Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •DES implantation within 12 months before index procedure
研究组 & 干预措施
P2Y12 antagonist monotherapy
P2Y12 antagonist monotherapy after 3-month DAPT
干预措施: P2Y12 antagonist monotherapy (Drug)
Aspirin + P2Y12 antagonist
Aspirin + P2Y12 antagonist after 3-month DAPT
干预措施: aspirin plus P2Y12 antagonist (Drug)
结局指标
主要结局
A composite of death, myocardial infarction, or cerebrovascular events
时间窗: 1 year
12 months after the index procedure
次要结局
- All cause Death(1 years)
- cardiac death(1 years)
- Myocardial infarction (MI)(1 years)
- BARC bleeding ≥2(1 years)
- Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization(1 years)
- Target vessel revascularization (TVR)(1 years)
- Stent thrombosis: definite or probable stent thrombosis by ARC definition(1 years)
- Cerebrovascular accident (CVA)(1 years)
- Any revascularization(1 years)
- BARC bleeding ≥3(1 years)
- Target lesion revascularization (TLR)(1 years)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center