CTIS2022-500125-32-00招募中1 期
Reduced antithrombotic strategy for high bleeding risk patients with myocardial infarction treated with percutaneous coronary intervention - The Dan-DAPT trial - 2022-500125-32-00
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 2,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.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 2.PRECISE-DAPT score =25 3.Age =18 years
排除标准
- •1.Contraindications including allergies to ASA or P2Y12 inhibitors 2.Indication for oral anticoagulation 3.Previous stent thrombosis 4.Life expectancy <1 year 5.Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation 6.Prior intracranial hemorrhage 7.Active bleeding (BARC =2) at randomization 8.Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception 9.Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg) 10.Unable to understand and follow study-related instructions or to comply with study protocol
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