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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by William Beaumont Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Pennsylvania
Johns Hopkins University
London Health Sciences Centre
Information provided by (Responsible Party):
David Haines, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01607359
First received: May 24, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 404
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)
Groups/Cohorts
dabigatran group
All patients receiving dabigatran as periprocedural anticoagulation during the study time period
warfarin group
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients undergoing catheter ablation for atrial fibrillation

Criteria

Inclusion Criteria:

  • All patients undergoing catheter ablation for atrial fibrillation

Exclusion Criteria:

  • none (retrospective trial)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607359

Locations
United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
University of Pennsylvania
Johns Hopkins University
London Health Sciences Centre
  More Information

No publications provided

Responsible Party: David Haines, MD, Director, Heart Rhythm Center, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01607359     History of Changes
Other Study ID Numbers: 2007088
Study First Received: May 24, 2012
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
atrial fibrillation
catheter ablation
dabigatran
warfarin
oral anticoagulation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Dabigatran
Warfarin
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014