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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-525121-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
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The goal of this clinical trial is to learn whether the antiarrhythmic drug flecainide can be used as safely as standard rhythm-control drugs in people with atrial fibrillation (AF) and stable coronary artery disease (CAD). The study includes adults aged 18 years and older who have AF and known but stable coronary artery disease.
The main questions this study aims to answer are:
Researchers will compare patients treated with flecainide to patients treated with standard rhythm-control therapy (sotalol or amiodarone) to see whether flecainide is not worse in terms of safety outcomes.
Participants will:
This study follows patients for at least one year and collects information on safety, heart rhythm outcomes, quality of life, and healthcare use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flecainide | Experimental | Flecainide, a class Ic anti-arrhythmic drug. |
|
| Sotalol or Amiodarone | Active Comparator | Class III anti-arrhythmic drug: sotalol or amiodarone as per physician preference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flecainide | Drug | Flecainide, a class Ic anti-arrhythmic drug Recommended starting dose of 100 to 150 mg per day per os, either spread in 2 equal doses BID or in 1 dose OD with controlled release formulation. Flecainide will always be combined with an AV nodal blocker (beta-blocker or diltiazem/verapamil). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite safety outcome | The primary outcome measure is a composite safety outcome including all-cause mortality, severe adverse events leading to drug discontinuation, and unscheduled hospitalisation for heart failure or acute coronary syndrome. Each of these individual components is assessed as secondary outcome. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death from any cause | 1 year |
| Severe adverse events leading to drug discontinuation | Any severe AE leading to intervention discontinuation, including bradyarrhythmias, ventricular arrhythmias, atrial flutter with 1:1 conduction, QT/QRS prolongation, serious extra-cardiac adverse events |
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Inclusion Criteria:
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
At least 18 years of age at the time of signing the Informed Consent Form
Non-permanent atrial fibrillation or ectopic atrial tachycardia with rhythm control strategy, documented on any modality in the 1 year preceding the consent date
Stable coronary artery disease without argument, defined as:
LVEF ≥ 45% documented on any imaging modality*
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joris Ector, MD PhD | Contact | +32 16 34 14 87 | Joris.Ector@UZLeuven.be | |
| Bert Vandenberk, MD PhD MSc | Contact | bert.vandenberk@uzleuven.be |
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Starting 12 months after publication
Upon reasonable request to the Principal Investigator
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| D013015 | Sotalol |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
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Multicenter, pragmatic, 2-arm, parallel group, open-label, individually randomised controlled non-inferiority trial
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| Sotalol or Amiodarone | Drug | Class III anti-arrhythmic drug: Sotalol or amiodarone as per physician preference. Recommended starting doses:
|
|
| 1 year |
| Unscheduled hospitalisation for heart failure or acute coronary syndrome | Unscheduled hospitalisation for heart failure or acute coronary syndrome | 1 year |
| AF recurrence | Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF) | 1 year |
| Major adverse cardiovascular events | Composite of cardiovascular death, myocardial infarction, stroke | 1 year |
| Catheter ablation | Incidence of catheter ablation for AF during follow-up | 1 year |
| Cardiovascular hospitalisation duration | Total number of days of cardiovascular hospitalisation | 1 year |
| Treatment-related adverse events | All serious adverse events and adverse events:
| 1 year |
| Cardiac function - LVEF | Changes in cardiac function assessed by left ventricular ejection fraction expressed in percentages (%) from baseline measured by echocardiography | 3 months |
| NT-proBNP | Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) at 3 months from baseline | 3 months |
| QTc | Change in QTc interval (ms) and QRS duration (ms) from baseline | 1 year |
| Healthcare resource utilization | Total within-trial healthcare resource utilization expressed in Euro (€) | 1 year |
| Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire | Change in patient reported outcomes assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. The AFEQT questionnaire is a 20-item, disease-specific, patient-reported outcome measure ranging from 0 to 100 with a higher value corresponding to a better quality of life. | 1 year |
| EuroQoL-5 dimension health utility index (EQ-5D-5L) | Change in patient-reported outcome as assessed by the EuroQoL-5 dimension health utility index (EQ-5D-5L) questionnaire. The EQ-5D-5L measures health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on five severity levels (1=no problem to 5=extreme problem). Results are interpreted via a 5-digit health state profile (e.g., 11211), a calculated utility index (ranging from <0 to 1, where 1=full health), and a 0-100 Visual Analog Scale (VAS). A higher score corresponds to a better quality of life. | 1 year |
| Short Form-12 (SF-12) health survey | Change in patient-reported outcome as assessed by the Short Form-12 (SF-12) health survey. The Short Form-12 (SF-12) health survey is interpreted by calculating two main, norm-based scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-where a score of 50 represents the average for the general population. Scores above 50 indicate better-than-average health-related quality of life, while scores below 50 indicate below-average health. | 1 year |
| EHRA symptom score | Change in patient-reported outcome as assessed by the European Heart Rhythm Association (EHRA) symptom score. The EHRA symptom score is a standardized, four-level classification system used to quantify the severity of symptoms in patients with atrial fibrillation based on how they impact daily activities. EHRA Symptom Score Classification (I-IV): EHRA I (Asymptomatic): No symptoms are experienced. EHRA II (Mild Symptoms): Normal daily activity is not affected. EHRA III (Severe Symptoms): Normal daily activity is affected. EHRA IV (Disabling Symptoms): Normal daily activity is discontinued. | 1 year |
| Work Productivity and Activity Impairment (WPAI) questionnaire | Change in patient-reported outcome as assessed by the Work Productivity and Activity Impairment (WPAI) questionnaire. The WPAI questionnaire is interpreted by calculating four key impairment percentages over the past 7 days, with higher scores (0-100%) indicating greater impairment and lower productivity. It measures absenteeism (time missed), presenteeism (impairment while working), overall work loss, and daily activity impairment, using a 0-10 scale for productivity. | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |