Dronedarone Rhythm Intervention for Early Atrial Fibrillation (DRIVE-AF)

Inha University Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: flecainide; Drug: Dronedarone; Drug: propafenone

Study type: Interventional

Funder types: Other

Identifiers

NCT07270848

2025-06-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,898 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• History of failure with prior antiarrhythmic drug therapy.
• 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).
• Diagnosis of permanent atrial fibrillation.
• 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.
• Known contraindications to dronedarone or Class Ic antiarrhythmic drugs.
• Participation in another clinical trial within 3 months prior to randomization.
• 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.
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,898 participants in 2 patient groups

Dronedarone

Experimental group

Description:

Participants assigned to this arm will receive dronedarone 400 mg twice daily.

Treatment:

Drug: Dronedarone

Class Ic Antiarrhythmic Drugs

Active Comparator group

Description:

Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice.

Treatment:

Drug: propafenone

Drug: flecainide