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Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation

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.
 
ClinicalTrials.gov Identifier: NCT01607359
Recruitment Status : Withdrawn (Withdrawn: It was decided not to proceed with the study at this time.)
First Posted : May 30, 2012
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
University of Pennsylvania
Johns Hopkins University
London Health Sciences Centre
Information provided by (Responsible Party):
William Beaumont Hospitals

Brief Summary:
Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.

Condition or disease
Atrial Fibrillation

Detailed Description:
  • Data from patients collected from 4 US and 1 Canadian medical center
  • Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.
  • Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.
  • Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.
  • Warfarin patients will be numbered sequentially
  • A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.

Patient data sets will be de-identified and compiled

  • Master data set to be stored in Excel file
  • Statistics to be performed with SAS (Cary, NC)
  • Continuous data to be expressed as means ± S.D., compared with unpaired t-tests
  • Categorical data will be compared with Fisher's exact test or Chi-square
  • Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 20, 2017


Group/Cohort
dabigatran group
All patients receiving dabigatran as periprocedural anticoagulation during the study time period
warfarin group
A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period.



Primary Outcome Measures :
  1. Clinical stroke, TIA or systemic embolic complication [ Time Frame: 30 days before or after catheter ablation ]
    Thromboembolic complication recorded in clinical records.

  2. Bleeding complication [ Time Frame: 30 days before or after catheter ablation ]
    Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.


Secondary Outcome Measures :
  1. Any significant complication [ Time Frame: 30 days before or after catheter ablation ]
    Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing catheter ablation for atrial fibrillation
Criteria

Inclusion Criteria:

  • All patients undergoing catheter ablation for atrial fibrillation

Exclusion Criteria:

  • none (retrospective trial)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607359


Locations
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United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
University of Pennsylvania
Johns Hopkins University
London Health Sciences Centre
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Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01607359    
Other Study ID Numbers: 2007088
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: December 2016
Keywords provided by William Beaumont Hospitals:
atrial fibrillation
catheter ablation
dabigatran
warfarin
oral anticoagulation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes