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Trial record 14 of 332 for:    DABIGATRAN

Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

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ClinicalTrials.gov Identifier: NCT03183843
Recruitment Status : Unknown
Verified June 2017 by Sergey Mamchur, Research Institute for Complex Problems of Cardiovascular Diseases, Russia.
Recruitment status was:  Enrolling by invitation
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Sergey Mamchur, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Stenosis and Insufficiency Atrial Fibrillation Drug: Dabigatran Etexilate Drug: Warfarin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 1, 2018


Arm Intervention/treatment
Active Comparator: Dabigatran
Dabigatran etexilate 150 mg by mouth every 12 hours for a year
Drug: Dabigatran Etexilate
Dabigatran Etexilate 150 mg capsules for oral administration twice a day
Other Name: Pradaxa

Active Comparator: Warfarin
Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year
Drug: Warfarin
Warfarin 2.5 mg tablets for oral administration once a day
Other Name: Coumadin




Primary Outcome Measures :
  1. Thrombosis [ Time Frame: 1 year ]
    Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events


Secondary Outcome Measures :
  1. Major Bleeding [ Time Frame: 1 year ]
    Massive symptomatic intracranial, intraocular, retroperitoneal, intraarticular, pericardial bleeding or intramuscular bleeding associated with compressive syndrome



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183843


Locations
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Russian Federation
Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, Russian Federation, 650061
Sponsors and Collaborators
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Investigators
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Study Chair: Yevgeny V Grigoriev, M.D., Ph.D. Research Institute for Complex Problems of Cardiovascular Diseases

Publications:
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Responsible Party: Sergey Mamchur, Head of Department of Cardiovascular Disorders Diagnosis, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
ClinicalTrials.gov Identifier: NCT03183843     History of Changes
Other Study ID Numbers: 0546-2015-0011
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sergey Mamchur, Research Institute for Complex Problems of Cardiovascular Diseases, Russia:
Atrial Fibrillation
Mitral Valve Stenosis
Mitral Valve Insufficiency
Dabigatran
Biological Prosthesis
Mitral Valve Replacement
Cox-Maze Procedure
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Mitral Valve Stenosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Valve Diseases
Warfarin
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action