Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement

Conditions
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Atrial Fibrillation, Mitral Valve Stenosis and Insufficiency

Intervention / Treatment
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* Drug: Dabigatran Etexilate
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mitral valve disease; atrial fibrillation; mitral valve prosthetic replacement with concomitant Cox-Maze Procedure; 18-75 years of age; signed informed consent form. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dabigatran<br>Dabigatran etexilate 150 mg by mouth every 12 hours for a year | Drug: Dabigatran Etexilate<br>* Dabigatran Etexilate 150 mg capsules for oral administration twice a day<br>* Other names: Pradaxa;|
| Active Comparator: Warfarin<br>Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year | Drug: Warfarin<br>* Warfarin 2.5 mg tablets for oral administration once a day<br>* Other names: Coumadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Bleeding | Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Mitral Valve Stenosis, Mitral Valve Insufficiency, Dabigatran, Biological Prosthesis, Mitral Valve Replacement, Cox-Maze Procedure