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临床试验/CTIS2022-502140-13-00
CTIS2022-502140-13-00招募中1 期

What is the optimal antithrombotic strategy in patients with atrial fibrillation having acute coronary syndrome or undergoing percutaneous coronary intervention?

St Antonius Hospital0 个研究点目标入组 2,550 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
2,550

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

年龄范围
18 至 65+(—)
性别
All

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)

研究者

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