2023-504360-42-00招募中4 期
Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Amsterdam UMC24 个研究点 分布在 2 个国家目标入组 3,090 人开始时间: 2023年4月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,090
- 试验地点
- 24
- 主要终点
- Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
结局指标
主要结局
Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months
Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months
Composite of all-cause mortality, myocardial infarction, and stroke at 12 months
Composite of all-cause mortality, myocardial infarction, and stroke at 12 months
次要结局
未报告次要终点
研究者
I.T. Küçük
Scientific
Amsterdam UMC
研究点 (24)
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