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Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation (DEPAF)

This study has been terminated.
(Not enough patients in time period allotted for study)
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah Identifier:
First received: February 15, 2012
Last updated: September 10, 2015
Last verified: September 2015
Results First Received: August 11, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Atrial Fibrillation
Intervention: Drug: Dabigatran etexilate (Pradaxa)

  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
medical clinic

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

Reporting Groups

Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant

Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year

Participant Flow:   Overall Study
Withdrawal by Subject                3 
Adverse Event                4 
Lost to Follow-up                2 
early closure of study                2 
other unrelated illness                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
Dabigatran Dabigatran

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 60  (12) 
[Units: Participants]
Female   10 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   14 

  Outcome Measures

1.  Primary:   Percentage of Fibrosis   [ Time Frame: MRI at baseline and MRI at 12 months post-enrollment ]

  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Clinical Research Manager
Organization: University of Utah
phone: 8015873889

Responsible Party: Nassir F. Marrouche, MD, University of Utah Identifier: NCT01546883     History of Changes
Other Study ID Numbers: IRB # 43119
Study First Received: February 15, 2012
Results First Received: August 11, 2015
Last Updated: September 10, 2015