Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
NCT03183843 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-06-12
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.
Conditions
- Mitral Valve Stenosis and Insufficiency
- Atrial Fibrillation
Interventions
- 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
Sponsors & Collaborators
-
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
lead OTHER
Principal Investigators
-
Yevgeny V Grigoriev, M.D., Ph.D. · Research Institute for Complex Problems of Cardiovascular Diseases
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-29
- Primary Completion
- 2018-06-30
- Completion
- 2018-12-01
Countries
- Russia
Study Locations
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