KCT0003387招募中未知
An open-label, randomized, controlled, multicenter study comparing two treatment strategies of Edoxaban alone and Edoxaban with antiplatelet agent in patients with atrial fibrillation and chronic stable coronary artery disease
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Subject was = 19 years of age
- •2.Patients with nonvalvular AF with high embolic risk (CHA2DS2-VASc score =2,VASc=vascular disease (peripheral arterial disease, previous MI, aortic atheroma))
- •3.Patients with Stable Coronary artery disease
- •?coronary angiography (CAG) or Coronary computed tomography angiography (CCTA) confirmed Coronary artery disease (=50 % stenosis of major coronary artery) on medical treatment
- •?Revascularized Coronary artery disease (either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)) whom the last revascularization should be performed =12 months before study enrollment for acute coronary syndrome and =6 months for stable angina pectoris.
排除标准
- •1.Patients with thrombocytopenia (platelet count <100,000/ul)
- •2.High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)
- •3.Prior history of intracranial haemorrhage or haemorrhage on Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) imaging test
- •4.Mechanical prosthetic valve or moderate to severe mitral stenosis
- •5.The risk of bleeding increased due to the following reasons;
- •i. history of gastrointestinal ulcers within 1 month
- •ii. Malignant tumor with high risk of bleeding
- •iii. Brain or spinal cord injury within 1 month
- •iv. History of intracranial or intracerebral hemorrhage within 12 months
- •v. Esophageal varices
- •vi. Arteriovenous malformation
- •vii. Vascular aneurysms
- •viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
- •ix. Active bleeding
- •x. Hemoglobin level <7.0 g/dL or platelet count = 50,000 / mm3
- •xi. History of major surgery within 1 month
- •6. Patients who contraindicated for edoxaban
- •7. Uncontrolled severe hypertension
- •8. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy
- •9.History of hypersensitivity to Edoxaban or clopidogrel
- •10.Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •11.Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization
- •12.Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality)
- •13.Estimated CrCl by Cockcroft-Gault equation<15 mL/min
- •14.Life expectancy less than 12 months
- •15.The subject was unable to provide written informed consent or participate in long-term follow-up
- •16.Pregnant and/or lactating women
- •17.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
研究者
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