NCT07270848

Dronedarone Rhythm Intervention for Early Atrial Fibrillation

A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,898 (estimated)
• Sponsor: Inha University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a prospective, multicenter, randomized, open-label trial designed to address a common clinical question in the management of recent-onset atrial fibrillation (AF). Following recent evidence supporting the benefits of an early rhythm-control strategy, both dronedarone and Class Ic antiarrhythmic drugs (AADs) are widely used. However, there is a lack of large-scale, prospective, randomized data directly comparing the efficacy, safety, and quality of life outcomes between these two treatment strategies in this specific population. The primary objective of the DRIVE-AF study is to compare the clinical outcomes of dronedarone versus standard Class Ic AADs (flecainide or propafenone) in patients with AF diagnosed within the past year. Approximately 1,898 participants will be enrolled at 16 centers in the Republic of Korea. Eligible participants who provide informed consent will be randomized in a 1:1 ratio to receive either dronedarone or a Class Ic AAD (investigator's choice of flecainide or propafenone). All participants will be followed for a minimum of 12 months. Efficacy will be primarily assessed by the recurrence of atrial fibrillation. Safety endpoints, particularly the rate of drug discontinuation due to adverse events, and patient-reported outcomes, including quality of life measured by the AF-QoL questionnaire, will be systematically collected and compared between the two groups.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DRUG	Dronedarone	Dronedarone 400 mg administered orally twice daily.
DRUG	flecainide	Administered orally according to standard clinical practice.
DRUG	propafenone	Administered orally according to standard clinical practice.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2025-12-08
• Last updated: 2025-12-22

Locations

16 sites across 1 country: South Korea