NCT01006876

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,584

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

November 2, 2009

Last Update Submit

May 19, 2015

Conditions

Thromboembolism

Keywords

coumadinperi-procedural thromboembolismRFCAhigh risk atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Absence of thromboembolic events 48 hours post-ablation

    48 hours

Secondary Outcomes (1)

  • Recurrence of AF and late thromboembolic events

    6 months

Study Arms (2)

Study Arm

ACTIVE COMPARATOR

Patients receive continuous Coumadin therapy throughout the study.

Drug: Coumadin

Control Arm

ACTIVE COMPARATOR

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

Interventions

CoumadinDRUG

Continuous oral Coumadin therapy through the catheter ablation procedure

Also known as: warfarin
Study Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with known bleeding disorders or inherited thrombophilic disorder
  • Patients with oral contraceptives or estrogen replacement therapy
  • Patients with prosthetic heart valves
  • Patients unable or willing to give informed consent
  • Contraindications for Coumadin therapy
  • Patients with CHADS2 score zero
  • Contraindication to undergoing an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (2)

  • Bawazeer GA, Alkofide HA, Alsharafi AA, Babakr NO, Altorkistani AM, Kashour TS, Miligkos M, AlFaleh KM, Al-Ansary LA. Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias. Cochrane Database Syst Rev. 2021 Oct 21;10(10):CD013504. doi: 10.1002/14651858.CD013504.pub2.

    PMID: 34674223DERIVED

  • Di Biase L, Burkhardt JD, Santangeli P, Mohanty P, Sanchez JE, Horton R, Gallinghouse GJ, Themistoclakis S, Rossillo A, Lakkireddy D, Reddy M, Hao S, Hongo R, Beheiry S, Zagrodzky J, Rong B, Mohanty S, Elayi CS, Forleo G, Pelargonio G, Narducci ML, Dello Russo A, Casella M, Fassini G, Tondo C, Schweikert RA, Natale A. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014 Jun 24;129(25):2638-44. doi: 10.1161/CIRCULATIONAHA.113.006426. Epub 2014 Apr 17.

    PMID: 24744272DERIVED

MeSH Terms

Conditions

Thromboembolism

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andrea Natale, MD

    Texas Cardiac Arrhythmia Institiute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical director

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2013

Study Completion

April 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

US(1)