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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | Active Comparator | Dabigatran etexilate 150 mg by mouth every 12 hours for a year |
|
| Warfarin | Active Comparator | Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran Etexilate | Drug | Dabigatran Etexilate 150 mg capsules for oral administration twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis | Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yevgeny V Grigoriev, M.D., Ph.D. | Research Institute for Complex Problems of Cardiovascular Diseases | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Complex Problems of Cardiovascular Diseases | Kemerovo | 650061 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26384981 | 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. | |
| 19683642 | 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. |
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| ID | Term |
|---|---|
| D008946 | Mitral Valve Stenosis |
| D001281 | Atrial Fibrillation |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Warfarin | Drug | Warfarin 2.5 mg tablets for oral administration once a day |
|
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |