Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-29

Study Completion Date

2018-12-01

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.

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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.

Conditions

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Mitral Valve Stenosis and Insufficiency Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dabigatran

Dabigatran etexilate 150 mg by mouth every 12 hours for a year

Group Type ACTIVE_COMPARATOR

Dabigatran Etexilate

Intervention Type DRUG

Dabigatran Etexilate 150 mg capsules for oral administration twice a day

Warfarin

Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Warfarin 2.5 mg tablets for oral administration once a day

Interventions

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Dabigatran Etexilate

Dabigatran Etexilate 150 mg capsules for oral administration twice a day

Intervention Type DRUG

Warfarin

Warfarin 2.5 mg tablets for oral administration once a day

Intervention Type DRUG

Other Intervention Names

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Pradaxa Coumadin

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No