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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Mitral Valve Stenosis and Insufficiency
• Intervention / Treatment: Drug: Dabigatran Etexilate; Drug: Warfarin

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation, 650061
    • Research Institute for Complex Problems of Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dabigatran; Dabigatran etexilate 150 mg by mouth every 12 hours for a year	Drug: Dabigatran Etexilate; Dabigatran Etexilate 150 mg capsules for oral administration twice a day; Other Names: Pradaxa
Active Comparator: Warfarin; Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year	Drug: Warfarin; Warfarin 2.5 mg tablets for oral administration once a day; Other Names: Coumadin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Investigators: Study Chair: Yevgeny V Grigoriev, M.D., Ph.D., Research Institute for Complex Problems of Cardiovascular Diseases

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2016
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Mitral Valve Insufficiency; Dabigatran; Mitral Valve Replacement; Mitral Valve Stenosis; Biological Prosthesis; Cox-Maze Procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Valve Diseases; Atrial Fibrillation; Mitral Valve Stenosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Warfarin
• Other Study ID Numbers: 0546-2015-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No