KCT0012323进行中（未招募）4 期
Net Clinical Benefit of Edoxaban versus Apixaban in Patients with Atrial Fibrillation and Coronary Artery Disease
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- All
入选标准
- •i) Patients must be at least 19 years of age
- •ii) Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VASc 2 or more)
- •iii) Documented coronary artery disease, defined as at least one of the following:
- •history of percutaneous coronary intervention (PCI)
- •history of coronary artery bypass grafting (CABG)
- •major epicardial coronary artery stenosis =50% on coronary computed tomography angiography (CCTA) or invasive coronary angiography
- •iv) Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
排除标准
- •i) Known hypersensitivity or contraindications to study medications (apixaban or edoxaban)
- •ii) Severe renal impairment (creatinine clearance <15 mL/min) or dialysis
- •iii) Active major bleeding
- •iv) Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate / severe mitral stenosis)
- •v) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment)
- •vi) Pregnant or lactating women
研究者
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