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Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01976507
First Posted: November 5, 2013
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University Medical Center
Results First Submitted: August 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Atrial Flutter
Intervention: Drug: dabigatran etexilate mesylate

  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
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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
  Description
Dabigatran Etexilate Mesylate

Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.

dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.


Participant Flow:   Overall Study
    Dabigatran Etexilate Mesylate
STARTED   101 
Received Initial Dose of Dabigatran   100 
COMPLETED   94 
NOT COMPLETED   7 
Adverse Event                6 
ablation not done, drug not given                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.
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Reporting Groups
  Description
Dabigatran Etexilate Mesylate

Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.

dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.


Baseline Measures
   Dabigatran Etexilate Mesylate 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Years]
Median (Standard Deviation)
 61  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      28  28.0% 
Male      72  72.0% 
Region of Enrollment 
[Units: Participants]
 
United States   100 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.   [ Time Frame: Within 4 months following procedure (+/- 4 days) ]

2.  Primary:   Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.   [ Time Frame: Within 4 months following procedure (+/- 4 days) ]

3.  Secondary:   Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.   [ Time Frame: Within 4 months following procedure (+/- 4 days) ]

4.  Secondary:   Number of Participants With Minor Bleeding Events   [ Time Frame: Within 4 months following procedure (+/- 4 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christopher Ellis
Organization: Vanderbilt University Medical Center
e-mail: christopher.ellis@Vanderbilt.Edu



Responsible Party: Christopher Ellis, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01976507     History of Changes
Other Study ID Numbers: 121204
First Submitted: October 29, 2013
First Posted: November 5, 2013
Results First Submitted: August 13, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017