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

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ClinicalTrials.gov Identifier: NCT01868243
Recruitment Status : Terminated (because a significant decrease of viable candidates for the study.)
First Posted : June 4, 2013
Results First Posted : October 9, 2015
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Primary Disease
Interventions: Drug: Dabigatran
Drug: Warfarin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg


Warfarin adjusted-dose

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

Participant Flow:   Overall Study
    Dabigatran   Warfarin
STARTED   15   12 
COMPLETED   15   11 
Death                0                1 

  Baseline Characteristics

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

Dabigatran 110 mg BID

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


Warfarin adjusted-dose

Warfarin: Warfarin adjusted-dose

Total Total of all reporting groups

Baseline Measures
   Dabigatran   Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   12   27 
[Units: Years]
Mean (Standard Deviation)
 49  (10)   46  (6)   47  (8) 
[Units: Participants]
Female   10   7   17 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
Brazil   15   12   27 

  Outcome Measures

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

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

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andre Duraes, PhD, Hospital Ana Nery
ClinicalTrials.gov Identifier: NCT01868243     History of Changes
Other Study ID Numbers: DAWA2013
First Submitted: May 28, 2013
First Posted: June 4, 2013
Results First Submitted: June 24, 2015
Results First Posted: October 9, 2015
Last Update Posted: October 9, 2015