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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
Sponsor:
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery

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
Enrollment 27

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg

Warfarin adjusted-dose

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

Period Title: Overall Study
Started 15 12
Completed 15 11
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title Dabigatran Warfarin Total
Hide Arm/Group Description

Dabigatran 110 mg BID

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

Warfarin adjusted-dose

Warfarin: Warfarin adjusted-dose

Total of all reporting groups
Overall Number of Baseline Participants 15 12 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 12 participants 27 participants
49  (10) 46  (6) 47  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Female
10
  66.7%
7
  58.3%
17
  63.0%
Male
5
  33.3%
5
  41.7%
10
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 15 participants 12 participants 27 participants
15 12 27
1.Primary Outcome
Title Intracardiac Thrombus
Hide Description The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg

Warfarin adjusted-dose

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

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
0
(0 to 0)
1
(0.9 to 1.3)
2.Secondary Outcome
Title Spontaneous Echo Contrast
Hide Description Spontaneous Echo Contrast showed in Transesophageal echocardiography
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg

Warfarin adjusted-dose

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

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: participants
2 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description

Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg

Warfarin adjusted-dose

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

All-Cause Mortality
Dabigatran Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/12 (0.00%)    
Nervous system disorders     
Stroke  [1]  1/15 (6.67%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Ischemic Stroke
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Dabigatran Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/12 (8.33%)    
Gastrointestinal disorders     
Bleeding  [1]  1/15 (6.67%)  1 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
Gastrointestinal bleeding
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
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