Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Atrial Fibrillation Clinical Trial

Official title:

The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03183843
• Other study ID #: 0546-2015-0011
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 8, 2017
• Last updated: June 8, 2017
• Start date: June 29, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2017
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Mitral Valve Stenosis
• Mitral Valve Stenosis and Insufficiency

Intervention

Drug:
• Dabigatran Etexilate
Dabigatran Etexilate 150 mg capsules for oral administration twice a day
• Warfarin
Warfarin 2.5 mg tablets for oral administration once a day

Locations

Country	Name	City	State
Russian Federation	Research Institute for Complex Problems of Cardiovascular Diseases	Kemerovo

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis	Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events	1 year
Secondary	Major Bleeding	Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome	1 year