This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor William Beaumont Hospitals
Collaborator University of Pennsylvania
Start date May 2012
End date July 2012
Trial size 404 participants
Trial identifier NCT01607359, 2007088


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
All patients receiving dabigatran as periprocedural anticoagulation during the study time period
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 Outcomes

Clinical stroke, TIA or systemic embolic complication
time frame: 30 days before or after catheter ablation
Bleeding complication
time frame: 30 days before or after catheter ablation

Secondary Outcomes

Any significant complication
time frame: 30 days before or after catheter ablation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients undergoing catheter ablation for atrial fibrillation Exclusion Criteria: - none (retrospective trial)

Additional Information

Official title Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.