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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Hospital Ana Nery
Sponsor:
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery
ClinicalTrials.gov Identifier:
NCT01868243
First received: May 28, 2013
Last updated: July 5, 2013
Last verified: July 2013

May 28, 2013
July 5, 2013
July 2013
July 2014   (final data collection date for primary outcome measure)
Embolic Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The primary efficacy end point was the composite of stroke (ischemic or hemorrhagic) and systemic embolism.
The primary efficacy end point was the composite of stroke (ischemic or hemorrhagic) and systemic embolism. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01868243 on ClinicalTrials.gov Archive Site
Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Major or minor bleeding. An individual occurrence of stroke, systemic embolism, or death from all causes.
A individual occurrence of stroke, systemic embolism, or death from all causes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively
Dabigatran Versus Warfarin After Mitral and Aortic Bioprosthesis Replacement for the Management of Atrial Fibrillation Postoperatively: Pilot Study

This randomized open study (pilot study) was designed to compare twice-daily oral Dabigatran with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in persistent or permanent atrial fibrillation after bioprosthesis replacement.

Between the period of August 2013 to July 2014, 100 patients with chronic rheumatic valve disease undergoing bioprosthetic valve replacement (mitral and/or aortic) in the cardiology service of Hospital Ana Nery in Salvador - Brazil, with persistent or permanent atrial fibrillation postoperatively will be selected to this randomized open pilot study.

By a process of simple randomization, half (50 patients) will use for 3 to 6 months of Dabigatran, and other half will use warfarin (the same period). Episodes of ischemic or hemorrhagic stroke, thromboembolism and bleeding (major and minor) will be closely observed.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Disease
  • Drug: Dabigatran
    Group 1 - Dabigatran 110 mg (50 patients)
    Other Name: Pradaxa® (dabigatran etexilate) 110mg twice daily
  • Drug: Warfarin
    Warfarin adjusted-dose
    Other Name: Warfarin adjusted-dose
  • Experimental: Dabigatran
    Dabigatran 110 mg BID
    Intervention: Drug: Dabigatran
  • Active Comparator: Warfarin
    Warfarin adjusted-dose
    Intervention: Drug: Warfarin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients between 18 and 64 years, with chronic rheumatic valvular disease after bioprosthesis replacement with permanent or persistent atrial fibrillation will be eligible;

Exclusion Criteria:

  • Previous stroke (ischemic or hemorrhagic)
  • Severe renal impairment (creatinine clearance rates <30 ml/mn);
  • active liver disease;
  • increased risk of bleeding;
  • uncontrolled hypertension;
Both
18 Years to 64 Years
No
Contact: Andre R Duraes, PhD 0557191888399 andreduraes@gmail.com
Brazil
 
NCT01868243
DAWA2013
Yes
Andre Duraes, PhD, Hospital Ana Nery
Hospital Ana Nery
Not Provided
Principal Investigator: Andre R Duraes, Professor Hospital Ana Nery
Hospital Ana Nery
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP