Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively (DAWA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dabigatran Versus Warfarin After Mitral and Aortic Bioprosthesis Replacement for the Management of Atrial Fibrillation Postoperatively: Pilot Study|
- 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.
- 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.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Dabigatran 110 mg BID
Group 1 - Dabigatran 110 mg (50 patients)
Other Name: Pradaxa® (dabigatran etexilate) 110mg twice daily
Active Comparator: Warfarin
Other Name: Warfarin adjusted-dose
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.
|Contact: Andre R Duraes, PhDfirstname.lastname@example.org|
|Hospital Ana Nery||Recruiting|
|Salvador, Bahia, Brazil, 40320010|
|Contact: Andre R Duraes 0557191888399 email@example.com|
|Principal Investigator: Andre R Duraes|
|Sub-Investigator: Bianca A Nunes|
|Sub-Investigator: Juliana QV Muniz|
|Sub-Investigator: Pollianna S Roriz|
|Sub-Investigator: Italvar NC Neto|
|Principal Investigator: Roque A Junior|
|Principal Investigator:||Andre R Duraes, Professor||Hospital Ana Nery|