NCT03183843

Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Stenosis and Insufficiency
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	Dabigatran Etexilate 150 mg capsules for oral administration twice a day
DRUG	Warfarin	Warfarin 2.5 mg tablets for oral administration once a day

Timeline

• Start date: 2016-06-29
• Primary completion: 2018-06-30
• Completion: 2018-12-01
• First posted: 2017-06-12
• Last updated: 2017-06-12

Locations

1 site across 1 country: Russia