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Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Primary Purpose

Mitral Valve Stenosis and Insufficiency, Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Dabigatran Etexilate
Warfarin
Sponsored by
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mitral Valve Stenosis and Insufficiency focused on measuring Atrial Fibrillation, Mitral Valve Stenosis, Mitral Valve Insufficiency, Dabigatran, Biological Prosthesis, Mitral Valve Replacement, Cox-Maze Procedure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research Institute for Complex Problems of Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dabigatran

Warfarin

Arm Description

Dabigatran etexilate 150 mg by mouth every 12 hours for a year

Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year

Outcomes

Primary Outcome Measures

Thrombosis
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events

Secondary Outcome Measures

Major Bleeding
Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome

Full Information

First Posted
June 8, 2017
Last Updated
June 8, 2017
Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT03183843
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran
Arm Type
Active Comparator
Arm Description
Dabigatran etexilate 150 mg by mouth every 12 hours for a year
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year
Intervention Type
Drug
Intervention Name(s)
Dabigatran Etexilate
Other Intervention Name(s)
Pradaxa
Intervention Description
Dabigatran Etexilate 150 mg capsules for oral administration twice a day
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Warfarin 2.5 mg tablets for oral administration once a day
Primary Outcome Measure Information:
Title
Thrombosis
Description
Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Major Bleeding
Description
Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yevgeny V Grigoriev, M.D., Ph.D.
Organizational Affiliation
Research Institute for Complex Problems of Cardiovascular Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Research Institute for Complex Problems of Cardiovascular Diseases
City
Kemerovo
ZIP/Postal Code
650061
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26384981
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.
Results Reference
background
PubMed Identifier
19683642
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.
Results Reference
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Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

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