Clinical trial NCT03183843: Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
Official title: The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mitral Valve Stenosis and Insufficiency
Atrial Fibrillation
Keywords: Atrial Fibrillation
Mitral Valve Stenosis
Mitral Valve Insufficiency
Dabigatran
Biological Prosthesis
Mitral Valve Replacement
Cox-Maze Procedure
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thrombosis
timeFrame: 1 year
Secondary outcomes:
measure: Major Bleeding
timeFrame: 1 year
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Problems of Cardiovascular Diseases
Study officials:
affiliation: Research Institute for Complex Problems of Cardiovascular Diseases
name: Yevgeny V Grigoriev, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Yadlapati A, Groh C, Malaisrie SC, Gajjar M, Kruse J, Meyers S, Passman R. Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. Clin Res Cardiol. 2016 Mar;105(3):268-72. doi: 10.1007/s00392-015-0919-z. Epub 2015 Sep 18.
citation: Sun JC, Davidson MJ, Lamy A, Eikelboom JW. Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.