Trial record 6 of 87 for:    Open Studies | "Warfarin"

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
  Purpose

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.


Condition Intervention Phase
Primary Disease
Drug: Dabigatran
Drug: Warfarin
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospital Ana Nery:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
Experimental: Dabigatran
Dabigatran 110 mg BID
Drug: Dabigatran
Group 1 - Dabigatran 110 mg (50 patients)
Other Name: Pradaxa® (dabigatran etexilate) 110mg twice daily
Active Comparator: Warfarin
Warfarin adjusted-dose
Drug: Warfarin
Warfarin adjusted-dose
Other Name: Warfarin adjusted-dose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Andre R Duraes, PhD 0557191888399 andreduraes@gmail.com

Locations
Brazil
Hospital Ana Nery Recruiting
Salvador, Bahia, Brazil, 40320010
Contact: Andre R Duraes    0557191888399    andreduraes@gmail.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         
Sponsors and Collaborators
Hospital Ana Nery
Investigators
Principal Investigator: Andre R Duraes, Professor Hospital Ana Nery
  More Information

Publications:
Responsible Party: Andre Duraes, PhD, Andre Rodrigues Duraes, Hospital Ana Nery
ClinicalTrials.gov Identifier: NCT01868243     History of Changes
Other Study ID Numbers: DAWA2013
Study First Received: May 28, 2013
Last Updated: July 5, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Ana Nery:
Atrial Fibrillation
Bioprosthesis
Stroke
Dabigatran
Warfarin

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014