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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronedarone | Experimental | Participants assigned to this arm will receive dronedarone 400 mg twice daily. |
|
| Class Ic Antiarrhythmic Drugs | Active Comparator | Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronedarone | Drug | Dronedarone 400 mg administered orally twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-Soo Baek, M.D., Ph.D. | Contact | +82-32-890-2200 | existsoo@inha.ac.kr | |
| Hyoung Seok Lee, M.D. | Contact | +82-32-890-3575 | hyoungseok_lee@inha.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | Incheon | 22332 | South Korea |
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.
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| flecainide | Drug | Administered orally according to standard clinical practice. |
|
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| propafenone | Drug | Administered orally according to standard clinical practice. |
|
|
| 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. | 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). | 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. | 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. | Up to 12 months |
| Korea University Ansan Hospital | Ansan | 15355 | South Korea |
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| Soonchunhyang University Bucheon Hospital | Bucheon-si | 14584 | South Korea |
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| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
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| Soonchunhyang University Cheonan Hospital | Cheonan | 31151 | South Korea |
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| Inje University Ilsan Paik Hospital | Goyang | 10380 | South Korea |
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| NHIS Ilsan Hospital | Goyang-si | 10444 | South Korea |
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| Myongji Hospital | Goyang-si | 10475 | South Korea |
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| Hanyang University Guri Hospital | Guri-si | 11923 | South Korea |
| Jeju National University Hospital | Jeju City | 63241 | South Korea |
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| Sejong Chungnam National University Hospital | Sejong | 30099 | South Korea |
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| Korea University Anam Hospital | Seoul | 02841 | South Korea |
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| Severance Hospital | Seoul | 03722 | South Korea |
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| Ewha Womans University Seoul Hospital | Seoul | 07804 | South Korea |
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| Korea University Guro Hospital | Seoul | 08308 | South Korea |
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| Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077764 | Dronedarone |
| D000088722 | Unmanned Aerial Devices |
| D005424 | Flecainide |
| D011405 | Propafenone |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000401 | Aircraft |
| D001359 | Aviation |
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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