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Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

NCT ID: NCT01991119

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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Atrial fibrillation is the most common arrhythmia requiring continuous therapy. Conversion to and maintenance of sinus rhythm is important. Propafenone and dronedarone has been used as treatment for maintenance of sinus rhythm after DC cardioversion. But there are no direct comparison study.

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

Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation Propafenone Dronedarone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propafenone

Propafenone group

Group Type ACTIVE_COMPARATOR

Propafenone

Intervention Type DRUG

Dronedarone

Dronedarone group

Group Type ACTIVE_COMPARATOR

Dronedarone

Intervention Type DRUG

Interventions

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Propafenone

Intervention Type DRUG

Dronedarone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young Keun On

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Keun On, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Cardiac and Vascular Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25134972 (View on PubMed)

Other Identifiers

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2011-03-085-001

Identifier Type: -

Identifier Source: org_study_id