2022-502140-13-00招募中4 期
What is the optimal antithrombotic strategy in patients with atrial fibrillation having acute coronary syndrome or undergoing percutaneous coronary intervention?
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,850
- 试验地点
- 42
- 主要终点
- The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI.
研究概览
简要总结
- To assess bleeding risk (i.e. safety) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.
- To assess ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.
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
- •≥18 years of age
- •Undergoing successful PCI
- •History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC
排除标准
- •Contra indication to edoxaban, aspirin or all P2Y12 inhibitors (e.g. kidney failure (eGFR <15) or allergy)
- •Life expectancy <1 year
- •Other oral anticoagulation than NOAC or acenocoumarol at randomization (e.g. fenprocoumon)
- •Active malignancy with metastases or non-curative treatment (e.g. palliative chemotherapy)
- •Known coagulopathy
- •Active bleeding on randomization
- •History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved
- •Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.
- •Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 10^9/L
- •Pregnancy or breast-feeding women
- •BMI >40 or bariatric surgery
- •Poor LV function (LVEF <30%) with proven slow-flow
- •<12 months after any stroke
- •CHA2DS2VASc score ≥7
- •Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism, mechanical heart valve prosthesis, intracardiac thrombus or apical aneurysm requiring OAC)
- •History of intracranial haemorrhage
- •Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
- •Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
结局指标
主要结局
The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI.
The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI.
The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
次要结局
- Key secondary endpoints include the primary safety and efficacy outcomes at 6 months after successful PCI.
- Exploratory analysis of the individual components of the main secondary endpoint
- Net clinical benefit comprising of major bleeding, myocardial infarction, stroke, systemic embolism, all cause death, and stent thrombosis
- Quality of life
研究者
A. Verburg
Scientific
St Antonius Hospital
研究点 (42)
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