NCT01991119

Brief Summary

the purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after DC cardioversion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2011

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

Study Start

First participant enrolled

May 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.4 years

First QC Date

November 7, 2013

Last Update Submit

November 17, 2013

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationPropafenoneDronedarone

Outcome Measures

Primary Outcomes (1)

  • recurrence of atrial fibrillation

    6 month

Study Arms (2)

Propafenone

ACTIVE COMPARATOR

Propafenone group

Drug: Propafenone

Dronedarone

ACTIVE COMPARATOR

Dronedarone group

Drug: Dronedarone

Interventions

PropafenoneDRUG
Propafenone
DronedaroneDRUG
Dronedarone

Eligibility Criteria

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

You may qualify if:

  • a patient with persistent atrial fibrillation who received successful DC cardioversion

You may not qualify if:

  • prior amiodarone use
  • NYHA class III or IV heart failure
  • Left ventricular ejection fraction \< 35%
  • second or third AV block
  • sick sinus syndrome
  • heart rate \< 50 beat per minute
  • myocardiac infarction within 3 months
  • pregnant women
  • severe hepatic dysfunction
  • QT prolongation \> 500ms or PR interval \> 180ms
  • history of hypersensitivity for drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac and Vascular Center

Seoul, Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Chun KJ, Byeon K, Im SI, Park KM, Park SJ, Kim JS, On YK. Efficacy of dronedarone versus propafenone in the maintenance of sinus rhythm in patients with atrial fibrillation after electrical cardioversion. Clin Ther. 2014 Sep 1;36(9):1169-75. doi: 10.1016/j.clinthera.2014.07.013. Epub 2014 Aug 16.

    PMID: 25134972DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

PropafenoneDronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsAmiodaroneBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Young Keun On, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 25, 2013

Study Start

May 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

KR(1)