Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,094
- 试验地点
- 1
- 主要终点
- Time-to-event: All-cause Mortality
研究概览
简要总结
Despite substantial evidence supporting the use of dual anti-platelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. We here propose an international randomised controlled trial of 18,318 patients with type 1 myocardial infarction allocated to differing durations of dual anti-platelet therapy. We will use electronic health record linkage to track duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This has the potential to define treatment duration, settle a major outstanding international controversy, and influence modern cardiology practice across the world.
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
- •Aged ≥18 years
- •Clinical diagnosis of Type 1 myocardial infarction within 12 weeks
- •In the opinion of the attending clinician requires dual anti-platelet therapy with aspirin and a P2Y12 receptor antagonist
- •Resident in the country of recruitment with their unique health identifier
- •The attending clinician has equipoise regarding the duration of therapy
- •Provision of informed consent
排除标准
- •Clear indication for specific duration of dual anti-platelet therapy
- •Type 2 myocardial infarction
- •Contraindication to aspirin or P2Y12 receptor antagonist
- •Non-resident in the country of recruitment
- •Previous recruitment into the trial
- •Inability or unwilling to give informed consent
研究组 & 干预措施
3 months dual anti-platelet therapy
3 months dual anti-platelet therapy.
干预措施: 3 months dual anti-platelet therapy (Other)
12 months dual anti-platelet therapy
12 months dual anti-platelet therapy.
干预措施: 12 months dual anti-platelet therapy (Other)
结局指标
主要结局
Time-to-event: All-cause Mortality
时间窗: Date of index MI to 15 months
Restricted Mean Survival Time
Incidence: All-cause Mortality
时间窗: Date of index MI to 15 months
Occurrence of event
次要结局
- Incidence: Non-cardiovascular Death (Including Fatal Bleeding)(Date of MI to 15 months)
- Time-to-event: Major Fatal and Non-fatal Bleeding(Date of MI to 15 months)
- Incidence: Major Fatal and Non-fatal Bleeding(Date of MI to 15 months)
- Time-to-event: Gastrointestinal Bleeding(Date of MI to 15 months)
- Incidence: Gastrointestinal Bleeding(Date of MI to 15 months)
- Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction(Date of MI to 15 months)
- Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction(Date of MI to 15 months)
- Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)(Date of MI to 15 months)
- Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)(Date of MI to 15 months)
- Time-to-event: Myocardial Infarction (Fatal and Non-fatal)(Date of MI to 15 months)
- Incidence: Myocardial Infarction (Fatal and Non-fatal)(Date of MI to 15 months)
- Incidence: Intracranial Haemorrhage(Date of MI to 15 months)
- Time-to-event: Coronary Revascularisation(Date of MI to 15 months)
- Incidence: Coronary Revascularisation(Date of MI to 15 months)
- Time-to-event: Stent Thrombosis(Date of MI to 15 months)
- Incidence: Stent Thrombosis(Date of MI to 15 months)
- Time-to-event: Thrombotic Stroke(Date of MI to 15 months)
- Incidence: Thrombotic Stroke(Date of MI to 15 months)
- Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding(Date of MI to 15 months)
- Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding(Date of MI to 15 months)
- Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)(Date of MI to 15 months)