Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation; Mitral Valve Stenosis and Insufficiency

Treatments: Drug: Warfarin; Drug: Dabigatran Etexilate

Study type: Interventional

Funder types: Other

Identifiers

NCT03183843

0546-2015-0011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Dabigatran

Active Comparator group

Description:

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

Treatment:

Drug: Dabigatran Etexilate

Warfarin

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin