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Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively

NCT01868243 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-10-09

Study results available
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Summary

DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be observed in this study is intracardiac thrombus. There are no formal primary or secondary clinical efficacy or safety outcomes because it is a pilot study.

Conditions

  • Primary Disease

Interventions

DRUG

Dabigatran

Group 1 - Dabigatran 110 mg (50 patients)

DRUG

Warfarin

Warfarin adjusted-dose

Sponsors & Collaborators

  • Hospital Ana Nery

    lead OTHER

Principal Investigators

  • Andre R Duraes, Professor · Hospital Ana Nery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • Brazil

Study Locations

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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 NCT01868243 on ClinicalTrials.gov