Dronedarone compared with flecainide or propafenone for early atrial fibrillation
Compares dronedarone with flecainide or propafenone in adults recently diagnosed with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Dronedarone Rhythm Intervention for Early Atrial Fibrillation
Key facts
- Where
- Ansan, Bucheon-si, Busan, Cheonan, Goyang, Goyang-si, Guri-si, Incheon, Jeju City, Sejong, Seoul, and Wŏnju, South KoreaSee the 16 sites
- Phase
- Phase 4
Where in South Korea
- Korea University Ansan HospitalAnsan, South KoreaNo longer taking part
- Soonchunhyang University Bucheon HospitalBucheon-si, South KoreaNo longer taking part
- Kosin University Gospel HospitalBusan, South KoreaNo longer taking part
- Soonchunhyang University Cheonan HospitalCheonan, South KoreaNo longer taking part
- Inje University Ilsan Paik HospitalGoyang, South KoreaNo longer taking part
- MyongJi HospitalGoyang-si, South KoreaNo longer taking part
- NHIS Ilsan HospitalGoyang-si, South KoreaNo longer taking part
- Hanyang University Guri HospitalGuri-si, South KoreaNo longer taking part
- Inha University HospitalIncheon, South KoreaNo longer taking part
- Jeju National University HospitalJeju City, South KoreaNo longer taking part
- Sejong Chungnam National University HospitalSejong, South KoreaNo longer taking part
- Ewha Womans University Seoul HospitalSeoul, South KoreaNo longer taking part
- Korea University Anam HospitalSeoul, South KoreaNo longer taking part
- Korea University Guro HospitalSeoul, South KoreaNo longer taking part
- Severance hospitalSeoul, South KoreaNo longer taking part
- Wonju Severance Christian HospitalWŏnju, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inha University Hospital
- Trial code
- NCT07270848
- Record updated
- 22 December 2025
- Original description
The purpose of this study is to compare two commonly used types of medicine for treating atrial fibrillation (also called AF), a condition that causes an irregular heart rhythm. This study is for adults who have been diagnosed with AF within the past year.Read full original descriptionShow less
A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation
The purpose of this study is to compare two commonly used types of medicine for treating atrial fibrillation (also called AF), a condition that causes an irregular heart rhythm. This study is for adults who have been diagnosed with AF within the past year.
Researchers want to find out which medicine is more effective, safer, and provides a better quality of life for patients needing to control their heart rhythm.
Participants who agree to join the study will be randomly assigned (like flipping a coin) to one of two groups:
Group 1: Will receive the medicine Dronedarone.
Group 2: Will receive a standard medicine from the 'Class Ic' group (such as flecainide or propafenone).
The study will follow participants for at least 12 months. Researchers will compare how well each medicine works to prevent AF from coming back. They will also carefully track any side effects and changes in participants' quality of life during the study.
Inclusion: Participants who have voluntarily provided written informed consent to participate; Adults aged 19 years or older; Life expectancy of at least 1 year; Diagnosis of atrial fibrillation within the past 1 year; Participants with an indication for antiarrhythmic drug therapy (Dronedarone or Class Ic agents).
Exclusion: History of failure with prior antiarrhythmic drug therapy; Known contraindications to dronedarone or Class Ic antiarrhythmic drugs; Participation in another clinical trial within 3 months prior to randomization; Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation; Confirmed severe structural heart disease (e.g., heart failure with reduced ejection fraction [LVEF <= 40%], moderate or severe mitral stenosis, mechanical heart valve replacement, or dilated cardiomyopathy); Severe renal impairment (eGFR < 30 mL/min/1.73m\^2 or on dialysis) or severe hepatic impairment (Child-Pugh class B or higher) that restricts the use of antiarrhythmic drugs; Diagnosis of permanent atrial fibrillation; Participants who do not agree to refrain from participating in another clinical trial within 14 days after their participation in this study ends; Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the study.