Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE)

This study has been completed.
Sponsor:
Collaborators:
University of Kansas
California Pacific Medical Center
Stanford University
Case Western Reserve University
Southlake Regional Health Centre
Catholic University, Italy
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01006876
First received: November 2, 2009
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This study aims to explore the risk of periprocedural thromboembolic events in continuous versus interrupted Coumadin therapy in a large, randomized high-risk patient population undergoing radio-frequency catheter ablation for atrial fibrillation.


Condition Intervention Phase
Thromboembolism
Drug: Coumadin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Coumadin in Preventing Periprocedural Thrombo-Embolism as a Complication of Radio Frequency Catheter Ablation in High-risk Atrial Fibrillation Patients

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Absence of thromboembolic events 48 hours post-ablation [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of AF and late thromboembolic events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1560
Study Start Date: January 2010
Study Completion Date: April 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study Arm
Patients receive continuous Coumadin therapy throughout the study.
Drug: Coumadin
Continuous oral Coumadin therapy through the catheter ablation procedure
Other Name: warfarin
Drug: Coumadin
Oral tablets, daily dose, till the therapeutic INR of 2-3 is achieved
Other Name: Warfarin
Active Comparator: Control Arm
Patients discontinue Coumadin 3-4 days prior to ablation and replace it with heparin until the end of the procedure and bridge low molecular weight heparin (LMWH) with Coumadin 48-72 hours after ablation.
Drug: Coumadin
Patients discontinue Coumadin 3-4 days prior to ablation and replace it with heparin until the end of the procedure and bridge low molecular weight heparin (LMWH) with Coumadin 48-72 hours after ablation.
Other Name: Warfarin
Drug: Coumadin
Oral tablets, daily dose, till the therapeutic INR of 2-3 is achieved
Other Name: Warfarin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age- 18-75 years
  2. Patients in paroxysmal, persistent or long-standing persistent (LSP) AF
  3. patients with CHADS2 score ≥ 1
  4. AF patients with INR in the range of 2.0-3.0 in the last 3-4 weeks prior to ablation

Exclusion Criteria:

  1. Patients with known bleeding disorders or inherited thrombophilic disorder
  2. Patients with oral contraceptives or estrogen replacement therapy
  3. Patients with prosthetic heart valves
  4. Patients unable or willing to give informed consent
  5. Contraindications for Coumadin therapy
  6. Patients with CHADS2 score zero
  7. Contraindication to undergoing an MRI
  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: NCT01006876

Locations
United States, Texas
St.David's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
University of Kansas
California Pacific Medical Center
Stanford University
Case Western Reserve University
Southlake Regional Health Centre
Catholic University, Italy
  More Information

No publications provided by Texas Cardiac Arrhythmia Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Natale, Medical director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01006876     History of Changes
Other Study ID Numbers: TCAI-COMPARE
Study First Received: November 2, 2009
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
coumadin
peri-procedural thromboembolism
RFCA
high risk atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Thrombosis
Warfarin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014