Dronedarone Rhythm Intervention for Early Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1898 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Atrial Fibrillation (AF)

Keywords

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Atrial Fibrillation Dronedarone Flecainide Propafenone Antiarrhythmic Drugs Rhythm Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Dronedarone

Dronedarone 400 mg administered orally twice daily.

Intervention Type DRUG

flecainide

Administered orally according to standard clinical practice.

Intervention Type DRUG

propafenone

Administered orally according to standard clinical practice.

Intervention Type DRUG

Other Intervention Names

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Multaq Drone Tab. Tambocor Rytmonorm

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yong-Soo Baek

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-Soo Baek, M.D., Ph.D.

Role: STUDY_CHAIR

Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine and Inha University Hospital, Incheon, Republic of Korea.

Reach out to these primary contacts for questions about participation or study logistics.

Yong-Soo Baek, M.D., Ph.D.

Role: CONTACT

Phone: +82-32-890-2200

Identifier Type: -

Identifier Source: org_study_id

Dronedarone Rhythm Intervention for Early Atrial Fibrillation

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Dronedarone

Dronedarone

Class Ic Antiarrhythmic Drugs

flecainide

propafenone

Interventions

Dronedarone

flecainide

propafenone

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Inha University Hospital

Responsible Party

Yong-Soo Baek

Principal Investigators

Yong-Soo Baek, M.D., Ph.D.

Locations

Inha University Hospital

Korea University Ansan Hospital

Soonchunhyang University Bucheon Hospital

Kosin University Gospel Hospital

Soonchunhyang University Cheonan Hospital

Inje University Ilsan Paik Hospital

NHIS Ilsan Hospital

Myongji Hospital

Hanyang University Guri Hospital

Jeju National University Hospital

Sejong Chungnam National University Hospital

Korea University Anam Hospital

Severance Hospital

Ewha Womans University Seoul Hospital

Korea University Guro Hospital

Wonju Severance Christian Hospital

Countries

Central Contacts

Yong-Soo Baek, M.D., Ph.D.

Hyoung Seok Lee, M.D.

Facility Contacts

Hyerim Park

Yong-Soo Baek, M.D., Ph.D.

Sangmi Oh

Seung-yong Shin, M.D., Ph.D.

Sunyoung Yoo

Hyung-oh Choi, M.D., Ph.D.

Eun-ah Park

Sungil Lim, M.D., Ph.D.

Jiwon Jeon

Hayoung Choi, M.D., Ph.D.

Hye-young Kye

June Namgung, M.D., Ph.D.

Saerom Kim

Hancheol Lee, M.D., Ph.D.

Jieun Park

Eui-seok Hwang, M.D., Ph.D.

Jin-hee Kim

Ki Yung Boo, M.D., Ph.D.

Heejin Choi

Minsoo Kim, M.D., Ph.D.

Yuri Kim

Jong-il Choi, M.D., Ph.D.

Juhye Song

Hee Tae Yu, M.D., Ph.D.

Soohee Kwon

Yeji Kim, M.D., Ph.D.

Yoonhee Choi

Dae-in Lee, M.D., Ph.D.

Goeun Seol

Youngjoon Park, M.D., Ph.D.