Efficacy of Propafenone Versus Dronedarone for the Mainte... | NCT01991119

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

NCT01991119

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

98Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Propafenone
Dronedarone

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 17, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propafenone	Active Comparator	Propafenone group	Drug: Propafenone
Dronedarone	Active Comparator	Dronedarone group	Drug: Dronedarone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propafenone	Drug		Propafenone
Dronedarone

Measure	Description	Time Frame
recurrence of atrial fibrillation		6 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young Keun On, MD, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiac and Vascular Center		Seoul	Seoul	135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25134972	Derived	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.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals
D000638	Amiodarone