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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01607359
• Other study ID #: 2007088
• Status: Withdrawn
• Start date: May 2012
• Est. completion date: April 20, 2017

Study information

• Verified date: December 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 20, 2017
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing catheter ablation for atrial fibrillation

Exclusion Criteria:

• none (retrospective trial)

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Beaumont Health System	Royal Oak	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Johns Hopkins University, London Health Sciences Centre, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical stroke, TIA or systemic embolic complication	Thromboembolic complication recorded in clinical records.	30 days before or after catheter ablation
Primary	Bleeding complication	Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.	30 days before or after catheter ablation
Secondary	Any significant complication	Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen	30 days before or after catheter ablation