The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Thrombosis
研究概览
简要总结
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.
详细描述
Patients with prosthetic mitral valves need a long-term anticoagulation therapy. After mitral valve replacement using mechanical prostheses warfarin is administrated during the whole life. Biological prostheses allows do discontinue anticoagulation 3 months after surgery in the absence of other risk factors of thrombosis especially atrial fibrillation. The common approach to patients with mitral valve disease and atrial fibrillation is mitral valve prosthetic replacement concomitant to Cox-Maze procedure. This allows to maintain sinus rhythm in 65-80% of patients. In the study the safety and efficacy of dabigatran in comparison with warfarin will be evaluated after the mitral valve surgery and Cox-Maze procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mitral valve disease;
- •atrial fibrillation;
- •mitral valve prosthetic replacement with concomitant Cox-Maze Procedure;
- •18-75 years of age;
- •signed informed consent form.
排除标准
- •mechanical valve replacement;
- •repeated mitral valve surgery;
- •coronary artery hemodynamically significant stenoses;
- •ventricular arrhythmias;
- •creatinine clearance <50 ml/min;
- •HAS-BLED score >3;
- •previous stroke or transient ischemic attack;
- •liver diseases;
- •neoplasia;
- •pregnancy;
- •simultaneous antiplatelet therapy;
- •allergic reactions on Dabigatran or Warfarin;
- •cognitive disorders.
研究组 & 干预措施
Dabigatran
Dabigatran etexilate 150 mg by mouth every 12 hours for a year
干预措施: Dabigatran Etexilate (Drug)
Warfarin
Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year
干预措施: Warfarin (Drug)
结局指标
主要结局
Thrombosis
时间窗: 1 year
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events
次要结局
- Major Bleeding(1 year)
研究者
Sergey Mamchur
Head of Department of Cardiovascular Disorders Diagnosis
Research Institute for Complex Problems of Cardiovascular Diseases, Russia