Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,090
- 试验地点
- 2
- 主要终点
- Bleeding endpoint
研究概览
简要总结
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.
Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.
Study design: Open-label, multicentre randomized controlled trial.
Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.
Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.
Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.
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
- Single (Outcomes Assessor)
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
- •Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
- •Successful PCI (according to the treating physician)
排除标准
- •Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
- •Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
- •Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
- •Planned surgical intervention within 12 months of PCI
- •Pregnant or breastfeeding women at time of enrolment
- •Participation in another trial with an investigational drug or device
研究组 & 干预措施
Interventional arm
No aspirin
干预措施: No aspirin (Drug)
Control arm
Aspirin (75-100 mg once daily)
干预措施: Aspirin (Drug)
结局指标
主要结局
Bleeding endpoint
时间窗: 12 months
The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding
Ischemic endpoint
时间窗: 12 months
The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke
次要结局
未报告次要终点
研究者
J.P.S Henriques
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)