Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

NCT03183843 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-12

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183843 on ClinicalTrials.gov