A Phase 4 interventional study of Dronedarone and flecainide in Atrial Fibrillation (AF), sponsored by Inha University Hospital. Not yet recruiting at 16 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Inha University Hospital · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants assigned to this arm will receive dronedarone 400 mg twice daily.
Drug: Dronedarone
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 · Drug: propafenone
Dronedarone 400 mg administered orally twice daily.
Also known as: Multaq, Drone Tab.
Administered orally according to standard clinical practice.
Also known as: Tambocor
Administered orally according to standard clinical practice.
Also known as: Rytmonorm
Efficacy : Recurrence of Atrial Fibrillation
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
Time frame: From randomization up to 12 months
Safety : Rate of Drug Discontinuation Due to Adverse Events
Percentage of participants who permanently discontinue the assigned study drug due to any adverse event (AE) or serious adverse event (SAE).
Time frame: Up to 12 months
Change in Atrial Fibrillation-Specific Quality of Life (AF-QoL)
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.
Time frame: The change in scores will be compared between enrollment (baseline) and the 12-month time point.
Medication Adherence
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.
Time frame: 6 months and 12 months
Comparison of Atrial Fibrillation Treatment Options
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).
Time frame: Up to 12 months
Incidence of Other Arrhythmias on Holter or Wearable Patch ECG
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.
Time frame: Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
To measure the incidence of: (a) cardiovascular death, (b) stroke, (c) hospitalization for worsening heart failure, and (d) hospitalization for acute coronary syndrome.
Time frame: Up to 12 months
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Inha University Hospital