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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03183843

Enrollment

Registered

2017-06-12

Start date

2016-06-29

Completion date

2018-12-01

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Mitral Valve Stenosis and Insufficiency

Keywords

Atrial Fibrillation, Mitral Valve Stenosis, Mitral Valve Insufficiency, Dabigatran, Biological Prosthesis, Mitral Valve Replacement, Cox-Maze Procedure

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.

Interventions

DRUGDabigatran Etexilate

Dabigatran Etexilate 150 mg capsules for oral administration twice a day

DRUGWarfarin

Warfarin 2.5 mg tablets for oral administration once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026