Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation|
- Clinical stroke, TIA or systemic embolic complication [ Time Frame: 30 days before or after catheter ablation ] [ Designated as safety issue: Yes ]Thromboembolic complication recorded in clinical records.
- Bleeding complication [ Time Frame: 30 days before or after catheter ablation ] [ Designated as safety issue: Yes ]Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.
- Any significant complication [ Time Frame: 30 days before or after catheter ablation ] [ Designated as safety issue: Yes ]Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607359
|United States, Michigan|
|Beaumont Health System|
|Royal Oak, Michigan, United States, 48073|