drugset / Trial / NCT03183843
Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
Phase 4
Unknown
40 enrolled
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2016-06-29
- Primary completion
- 2018-06-30
- Completion
- 2018-12-01
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dabigatran etexilate | Unknown | 150 mg | Oral |
| Comparator | Warfarin | Small molecule | 2.5 mg | Oral |