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

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ClinicalTrials.gov Identifier: NCT01546883
Recruitment Status : Terminated (Not enough patients in time period allotted for study)
First Posted : March 7, 2012
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Atrial Fibrillation
Intervention Drug: Dabigatran etexilate (Pradaxa)
Enrollment 14
Recruitment Details medical clinic
Pre-assignment Details  
Arm/Group Title Dabigatran
Hide Arm/Group Description

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

Period Title: Overall Study
Started 14
Completed 2
Not Completed 12
Reason Not Completed
Withdrawal by Subject             3
Adverse Event             4
Lost to Follow-up             2
early closure of study             2
other unrelated illness             1
Arm/Group Title Dabigatran
Hide Arm/Group Description Dabigatran
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
60  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Percentage of Fibrosis
Hide Description We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.
Time Frame MRI at baseline and MRI at 12 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for the analysis population and therefore could not be summarized to include in this report.
Arm/Group Title Dabigatran
Hide Arm/Group Description:
Dabigatran
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran
Hide Arm/Group Description Patients taking Dabigatran
All-Cause Mortality
Dabigatran
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Gastrointestinal disorders   
GI bleed  [1]  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
[1]
Patient suffered a GI bleed which was later determined to be expected and not associated with the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dabigatran
Affected / at Risk (%) # Events
Total   9/14 (64.29%)    
Gastrointestinal disorders   
abdominal pain   2/14 (14.29%)  2
rectal bleeding   1/14 (7.14%)  1
lesions on tongue   1/14 (7.14%)  1
General disorders   
shortness of breath, dizziness, fatigue   3/14 (21.43%)  3
Infections and infestations   
respiratory tract infection   1/14 (7.14%)  1
urinary tract infection   1/14 (7.14%)  1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Manager
Organization: University of Utah
Phone: 8015873889
EMail: christina.pacchia@hsc.utah.edu
Layout table for additonal information
Responsible Party: Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01546883     History of Changes
Other Study ID Numbers: IRB # 43119
First Submitted: February 15, 2012
First Posted: March 7, 2012
Results First Submitted: August 11, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015