Antiplatelet therapy after successful percutaneous coronary intervention for chronically occluded coronary artery: A prospective, multicentre, randomized study comparing two durations of dual antiplatelet therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 11
- 主要终点
- Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event
研究概览
简要总结
To assess the efficacy of a short DAPT of 1 month, in comparison with usual long DAPT (6 to 12 months) on the incidence rate over 12 months of net adverse clinical events (bleeding and/or ischemic events) in patients treated by coronary angioplasty for chronic total occlusion
研究设计
- 分配方式
- Randomized
- 主要目的
- Inclusion + Follow Up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent a successful coronary stent implantation for chronic coronary occlusion, eligible for long-term aspirin therapy and requiring a dual antiplatelet therapy
- •Affiliated to Social Security system
- •Signature of informed consent
- •Age > 18 years old
排除标准
- •Dual antiplatelet therapy contra-indication
- •Patient with hypersensitivity to aspirin (or any of its excipients) and/or to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel)
- •Patient with contraindication to aspirin and/or clopidogrel
- •No coronary stent implanted
- •Age<18years
- •Patient under guardianship
- •Pregnancy or breast feeding
- •Prasugrel or ticagrelor use
结局指标
主要结局
Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event
Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event
次要结局
- Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death
- Time-to-bleeding event defined according to BARC classification (BARC 2 to BARC 5) over 12 months follow up, taking into account the competing risk of death from non-haemorrhagic cause, or time to last follow-up in case of no bleeding event
- Major adverse ischemic clinical events (MACE): time-to-composite endpoint of ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina over 12 months follow-up, taking into account the competing risk of death from non-cardiovascular cause, or time to last follow-up in case of no MACE
- Compliance to drug regimen at 1-, 6- and 12-months follow-up
- Total costs in each treatment group over the one-year study period
- Total quality-adjusted life years in each treatment group over the one-year study period
- Long-term cost-utility ratio (expressed in terms of additional costs per quality adjusted life year gained)
研究者
coordinator investigator
Scientific
Assistance Publique Hopitaux De Marseille