Reduced antithrombotic strategy for high bleeding risk patients with myocardial infarction treated with percutaneous coronary intervention - The Dan-DAPT trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,700
- 试验地点
- 5
- 主要终点
- The primary composite endpoints are: • The NACE (net adverse clinical events) endpoint is a composite of all-cause mortality, recurrent myocardial infarc, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleedings after 12 months • Bleeding Academic Research Consortium (BARC) type 2-5 non-access site bleeding after 12 months
研究概览
简要总结
This trial aims to improve existing dual antiplatelet therapy (DAPT) routines by assessing if patients with myocardial infarction, who are at high bleeding risk, can be safely allocated to an individualized, de-escalated DAPT strategy with clopidogrel using Cytochrome P2C19-genotyping and shorter duration of DAPT to reduce bleedings without increasing the risk of ischemic events.
研究设计
- 分配方式
- Randomized
- 主要目的
- Dan-dapt
- 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
- •Inclusion criteria:
- •MI caused by atherothrombotic CAD (Type 1 MI) according to “The Fourth Universal Definition of MI”, which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician: • symptoms indicating acute myocardial ischemia • new ischemic changes on the electrocardiogram • development of pathological Q-waves • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology • visible coronary thrombus by angiography
- •PRECISE-DAPT score ≥25
- •Age ≥18 years
排除标准
- •Contraindications including allergies to ASA or P2Y12 inhibitors
- •Indication for oral anticoagulation
- •Previous stent thrombosis
- •Life expectancy <1 year
- •Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
- •Prior intracranial hemorrhage
- •Active bleeding (BARC ≥2) at randomization
- •Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
- •Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)
- •Unable to understand and follow study-related instructions or to comply with study protocol
结局指标
主要结局
The primary composite endpoints are: • The NACE (net adverse clinical events) endpoint is a composite of all-cause mortality, recurrent myocardial infarc, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleedings after 12 months • Bleeding Academic Research Consortium (BARC) type 2-5 non-access site bleeding after 12 months
The primary composite endpoints are: • The NACE (net adverse clinical events) endpoint is a composite of all-cause mortality, recurrent myocardial infarc, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleedings after 12 months • Bleeding Academic Research Consortium (BARC) type 2-5 non-access site bleeding after 12 months
次要结局
未报告次要终点
研究者
Rikke Sorensen
Scientific
Rigshospitalet