NCT01991951

Brief Summary

We hypothesized that in patients with low CHADS-VASc score (2 or \< 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

November 18, 2013

Last Update Submit

November 21, 2013

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of thromboembolic and bleeding events during 2 months

    2 months after the procedure

Study Arms (2)

Short term warfarin group

EXPERIMENTAL

taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation

Drug: warfarin

Conventional therapy arm

ACTIVE COMPARATOR

conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF

Drug: warfarin

Interventions

warfarinDRUG
Conventional therapy armShort term warfarin group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
  • Patients with CHADS-VASc score 2 or less than 2

You may not qualify if:

  • Patients who do not consent to the study
  • Permanent or persistent atrial fibrillation
  • Patients who have underwent prior catheter ablation for atrial fibrillation
  • CHADS-VASc score more than 2
  • History of stroke
  • LVEF \<40%
  • Significant liver or kidney dysfunction
  • History of major bleeding during warfarin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jaemin Shim, MD

CONTACT

82-10-6776-1195jshim@kumc.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of medicine

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2017

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

KR(1)