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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868243
|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|