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

This study has been terminated.
(because a significant decrease of viable candidates for the study.)
Sponsor:
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery
ClinicalTrials.gov Identifier:
NCT01868243
First received: May 28, 2013
Last updated: September 14, 2015
Last verified: September 2015
Results First Received: June 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Disease
Interventions: Drug: Dabigatran
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dabigatran

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg

Warfarin

Warfarin adjusted-dose

Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)


Participant Flow:   Overall Study
    Dabigatran     Warfarin  
STARTED     15     12  
COMPLETED     15     11  
NOT COMPLETED     0     1  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dabigatran

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)

Warfarin

Warfarin adjusted-dose

Warfarin: Warfarin adjusted-dose

Total Total of all reporting groups

Baseline Measures
    Dabigatran     Warfarin     Total  
Number of Participants  
[units: participants]
  15     12     27  
Age  
[units: years]
Mean (Standard Deviation)
  49  (10)     46  (6)     47  (8)  
Gender  
[units: participants]
     
Female     10     7     17  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
Brazil     15     12     27  



  Outcome Measures
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1.  Primary:   Intracardiac Thrombus   [ Time Frame: 90 days ]

2.  Secondary:   Spontaneous Echo Contrast   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andre Rodrigues Duraes
Organization: Hospital Ana Nery
phone: +557191888399
e-mail: andreduraes@gmail.com


Publications:

Responsible Party: Andre Duraes, PhD, Hospital Ana Nery
ClinicalTrials.gov Identifier: NCT01868243     History of Changes
Other Study ID Numbers: DAWA2013
Study First Received: May 28, 2013
Results First Received: June 24, 2015
Last Updated: September 14, 2015
Health Authority: Brazil: Ethics Committee