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Recruitment Status : Withdrawn (Withdrawn: It was decided not to proceed with the study at this time.)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
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
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.
- Clinical stroke, TIA or systemic embolic complication [ Time Frame: 30 days before or after catheter ablation ]Thromboembolic complication recorded in clinical records.
- 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.
- 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
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
|United States, Michigan|
|Beaumont Health System|
|Royal Oak, Michigan, United States, 48073|