PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,258
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).
详细描述
In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).
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
- •Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
- •STEMI patients
- •Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months
排除标准
- •Patients taking anticoagulants
- •Patients under 18 years old
- •Patients with less than 1 year prognosis
- •Patients participating in other intervention studies
研究组 & 干预措施
No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).
干预措施: No aspirin (Prasugurel monotherapy) (Drug)
12-month DAPT
To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).
干预措施: 12-month DAPT (Drug)
结局指标
主要结局
Major adverse cardiovascular events
时间窗: 12 months
Composite of all-cause death, myocardial infarction, or stroke
次要结局
- Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- All-cause death(12 months)
- Target vessel failure(12 months)
- Ischemic stroke(12 months)
- Target lesion failure(12 months)
- Non-cardiovascular death(12 months)
- Myocardial infarction (Periprocedual/ Spontaneous)(12 months)
- Hemorrhagic stroke(12 months)
- Patient-Oriented Composite Endpoint(12 months)
- Any target lesion revascularization(12 months)
- Coronary artery bypass grafting(12 months)
- Any coronary revascularization(12 months)
- Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria(12 months)
- Intracranial bleeding(12 months)
- Cardiovascular death(12 months)
- Stroke (Ischemic/ Haemorrhagic)(12 months)
- Stent thrombosis(12 months)
- Clinically-driven target lesion revascularization(12 months)
- Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria(12 months)
- Gastrointestinal complaints(12 months)
- Any target vessel revascularization(12 months)
- Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Gastrointestinal bleeding(12 months)
- Non-target lesion revascularization(12 months)
- Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria(12 months)