Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propafenone
Dronedarone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Propafenone, Dronedarone
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
Sites / Locations
- Cardiac and Vascular Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propafenone
Dronedarone
Arm Description
Propafenone group
Dronedarone group
Outcomes
Primary Outcome Measures
recurrence of atrial fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT01991119
First Posted
November 7, 2013
Last Updated
November 17, 2013
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01991119
Brief Title
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Official Title
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation After DC Cardioversion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Propafenone, Dronedarone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propafenone
Arm Type
Active Comparator
Arm Description
Propafenone group
Arm Title
Dronedarone
Arm Type
Active Comparator
Arm Description
Dronedarone group
Intervention Type
Drug
Intervention Name(s)
Propafenone
Intervention Type
Drug
Intervention Name(s)
Dronedarone
Primary Outcome Measure Information:
Title
recurrence of atrial fibrillation
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Keun On, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25134972
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
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