Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Phase 4

• Conditions: Mitral Valve Stenosis and Insufficiency; Atrial Fibrillation
• Interventions: Drug: Dabigatran Etexilate; Drug: Warfarin

• Registration Number: NCT03183843
• Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Brief Summary

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

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 Timeline

• Study Start: 2016-06-29
• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dabigatran	Dabigatran Etexilate	Dabigatran etexilate 150 mg by mouth every 12 hours for a year
Warfarin	Warfarin	Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year

Primary Outcome Measures

Name	Time	Method
Thrombosis	1 year	Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events

Secondary Outcome Measures

Name	Time	Method
Major Bleeding	1 year	Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome

Trial Locations

Locations (1)

Research Institute for Complex Problems of Cardiovascular Diseases; 🇷🇺 Kemerovo, Russian Federation