Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01607359
Status:
WITHDRAWN
Last Update Posted:
2023-05-11
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn: It was decided not to proceed with the study at this time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: