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

December 15, 2025 updated by: Yong-Soo Baek, Inha University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1898

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Ansan, South Korea, 15355
        • Korea University Ansan Hospital
        • Contact:
        • Contact:
      • Bucheon-si, South Korea, 14584
        • Soonchunhyang University Bucheon Hospital
        • Contact:
        • Contact:
      • Busan, South Korea, 49267
      • Cheonan, South Korea, 31151
        • Soonchunhyang University Cheonan Hospital
        • Contact:
        • Contact:
      • Goyang, South Korea, 10380
        • Inje University Ilsan Paik Hospital
        • Contact:
        • Contact:
      • Goyang-si, South Korea, 10444
      • Goyang-si, South Korea, 10475
        • Myongji Hospital
        • Contact:
        • Contact:
      • Guri-si, South Korea, 11923
        • Hanyang University Guri Hospital
      • Jeju City, South Korea, 63241
        • Jeju National University Hospital
        • Contact:
        • Contact:
      • Sejong, South Korea, 30099
        • Sejong Chungnam National University Hospital
        • Contact:
        • Contact:
      • Seoul, South Korea, 03722
        • Severance Hospital
        • Contact:
        • Contact:
          • Hee Tae Yu, M.D., Ph.D.
          • Phone Number: +82-1599-1004
          • Email: HEETYU@yuhs.ac
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
        • Contact:
        • Contact:
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
        • Contact:
        • Contact:
      • Seoul, South Korea, 07804
        • Ewha Womans University Seoul Hospital
        • Contact:
        • Contact:
      • Wŏnju, South Korea, 26426
        • Wonju Severance Christian Hospital
        • Contact:
        • Contact:
          • Youngjoon Park, M.D., Ph.D.
          • Phone Number: +82-33-741-0114
          • Email: pyj@yonsei.ac.kr
    • Incheon
      • Incheon, Incheon, South Korea, 22332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dronedarone
Participants assigned to this arm will receive dronedarone 400 mg twice daily.
Drug: Dronedarone
Dronedarone 400 mg administered orally twice daily.
Other Names:
  • Multaq
  • Drone Tab.
Active Comparator: Class Ic Antiarrhythmic Drugs
Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice.
Drug: flecainide
Administered orally according to standard clinical practice.
Other Names:
  • Tambocor
Drug: propafenone
Administered orally according to standard clinical practice.
Other Names:
  • Rytmonorm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy : Recurrence of Atrial Fibrillation
Time Frame: From randomization up to 12 months
Percentage of participants who experience a recurrence of atrial fibrillation (AF), atrial flutter, or atrial tachycardia lasting 30 seconds or more, as documented by 12-lead ECG, 24-hour Holter monitoring or wearable Holter monitoring
From randomization up to 12 months
Safety : Rate of Drug Discontinuation Due to Adverse Events
Time Frame: Up to 12 months
Percentage of participants who permanently discontinue the assigned study drug due to any adverse event (AE) or serious adverse event (SAE).
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Atrial Fibrillation Treatment Options
Time Frame: Up to 12 months
To assess the rates of: (a) use of Non-vitamin K Antagonist Oral Anticoagulants (NOACs), (b) use of medical therapy (rate control and rhythm control), (c) atrial fibrillation catheter ablation, and (d) direct current cardioversion (DCCV).
Up to 12 months
Incidence of Other Arrhythmias on Holter or Wearable Patch ECG
Time Frame: Up to 12 months
To compare the detection rate of other arrhythmias (e.g., Premature Atrial Contractions (PAC), Premature Ventricular Contractions (PVC), Atrioventricular (AV) Block, Supraventricular Tachycardia (SVT), and Ventricular Tachycardia (VT)) documented by Holter or wearable patch ECG monitoring.
Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: Up to 12 months
To measure the incidence of: (a) cardiovascular death, (b) stroke, (c) hospitalization for worsening heart failure, and (d) hospitalization for acute coronary syndrome.
Up to 12 months
Change in Atrial Fibrillation-Specific Quality of Life (AF-QoL)
Time Frame: The change in scores will be compared between enrollment (baseline) and the 12-month time point.
The impact of early rhythm control on quality of life will be assessed using the Atrial Fibrillation Quality of Life (AF-QoL) questionnaire. This questionnaire includes items related to psychological, physical, and sexual activity. The total score is standardized to a scale ranging from 0 to 100, with higher scores indicating a better quality of life.
The change in scores will be compared between enrollment (baseline) and the 12-month time point.
Medication Adherence
Time Frame: 6 months and 12 months
The proportion of patients who remain on the assigned study medication will be measured. Adherence will be assessed using the Proportion of Days Covered (PDC) calculation. A PDC of 80% or greater is defined as adherent.
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Investigators

  • Study Chair: Yong-Soo Baek, M.D., Ph.D., Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine and Inha University Hospital, Incheon, Republic of Korea.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-06-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect the privacy of study participants. The informed consent form signed by the participants does not include a provision for data sharing with third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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