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

NCT01006876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1584

Last updated 2015-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Thromboembolism

Interventions

DRUG

Coumadin

Continuous oral Coumadin therapy through the catheter ablation procedure

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.

DRUG

Coumadin

Oral tablets, daily dose, till the therapeutic INR of 2-3 is achieved

Sponsors & Collaborators

  • University of Kansas

    collaborator OTHER

  • California Pacific Medical Center

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Southlake Regional Health Centre

    collaborator OTHER

  • Catholic University, Italy

    collaborator OTHER

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Institiute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-03-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006876 on ClinicalTrials.gov