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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Dabigatran Etexilate 150 mg capsules for oral administration twice a day
Warfarin 2.5 mg tablets for oral administration once a day
Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, Russia
Thrombosis
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events
Time frame: 1 year
Major Bleeding
Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome
Time frame: 1 year
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