Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation (ReCAST AF)

September 11, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

Randomized Evaluation of fleCAinide Safety Versus STandard of Care in Patients With Coronary Artery Disease and Atrial Fibrillation

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:

  • Is treatment with flecainide as safe as standard rhythm-control drugs (sotalol or amiodarone) in this patient group?
  • Does flecainide lead to similar or fewer serious side effects, hospitalisations, or deaths compared with standard treatment?

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:

  • Be randomly assigned to receive either flecainide or standard rhythm-control medication
  • Take the assigned medication as part of routine clinical care
  • Attend regular follow-up visits at the hospital and have additional follow-up by telephone
  • Undergo routine heart tests such as electrocardiograms and echocardiography
  • Complete questionnaires about symptoms, quality of life, and daily functioning

This study follows patients for at least one year and collects information on safety, heart rhythm outcomes, quality of life, and healthcare use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
988

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
      • Bonheiden, Belgium, 2820
      • Bruges, Belgium, 8000
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
      • Genk, Belgium, 3600
        • Not yet recruiting
        • Ziekenhuis Oost Limburg
        • Contact:
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • Az Maria Middelares Gent
        • Contact:
      • Herentals, Belgium, 2200
      • Ieper, Belgium, 8900
        • Not yet recruiting
        • Jan Yperman Ziekenhuis
        • Contact:
      • Kortrijk, Belgium, 8500
        • Not yet recruiting
        • Algemeen Ziekenhuis Groeninge
        • Contact:
      • Leuven, Belgium, 3000
      • Roeselare, Belgium, 8800
        • Not yet recruiting
        • Algemeen Ziekenhuis Delta
        • Contact:
      • Rumst, Belgium, 2840
        • Not yet recruiting
        • AZ Rivierenland
        • Contact:
      • Sint-Niklaas, Belgium, 9100
      • Turnhout, Belgium, 2300

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. At least 18 years of age at the time of signing the Informed Consent Form
  3. Non-permanent atrial fibrillation or ectopic atrial tachycardia with rhythm control strategy, documented on any modality in the 1 year preceding the consent date

  4. Stable coronary artery disease without argument, defined as:

    1. Prior percutaneous coronary intervention; OR
    2. Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR
    3. Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR
    4. Coronary CT scan showing coronary stenosis CAD-RADS stage ≥ 3 on, including CAD-RADS stages 4 and 5 in the absence of ischemia on exercise testing, myocardial perfusion imaging (MIBI), stress cardiac MRI, or fractional flow reserve.
  5. LVEF ≥ 45% documented on any imaging modality*

Exclusion Criteria:

  1. LVEF < 45%
  2. NYHA class III or IV congestive heart failure
  3. Active treatment with amiodarone
  4. History of intolerance of flecainide or both sotalol and amiodarone
  5. Clinically significant uncorrected hypokalemia or hypomagnesemia before initiation of trial treatment.
  6. Evidence or history of thyroid dysfunction contraindicating amiodarone use, where amiodarone would be prescribed as standard of care treatment.
  7. Hypersensitivity to the active substances or any excipients.
  8. Unstable angina or inducible ischemia on exercise stress testing, myocardial perfusion imaging, stress cardiac MRI, or fractional flow reserve performed for clinical indications
  9. Baseline QRS duration ≥ 120 ms, unless a functioning pacemaker is present
  10. Baseline corrected QT interval (Fridericia) ≥ 500 ms 11 Pre-existing advanced AV block (second-, or third-degree)

12. Pre-existing sick sinus syndrome or sinus bradycardia <50 bpm 13. Known channelopathy 14. Contra-indication to AV-slowing agents, including beta-blockers, diltiazem or verapamil 15. Atrial fibrillation due to reversible cause 16. Active intracardiac thrombus 17. Acute coronary syndrome during the 3-month period preceding the consent date 18. Cardiac surgery, including coronary artery bypass surgery, during the 3-month period preceding the consent date or planned at a future date at the time of consent 19. Moderate or severe congenital heart disease as per 2020 ESC guidelines 20. Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm) 21. Significant chronic kidney disease (eGFR <40 mL/min) 22. Life expectancy less than 1 year 23. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 24. Inability to provide written informed consent, including decision-making incapacity due to cognitive impairment or other medical or psychiatric conditions that preclude adequate understanding of the study and its procedures.

25. Participation in an interventional Trial with an investigational medicinal product (IMP) or device

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Flecainide
Flecainide, a class Ic anti-arrhythmic drug.
Drug: flecainide

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).
Active Comparator: Sotalol or Amiodarone
Class III anti-arrhythmic drug: sotalol or amiodarone as per physician preference.
Drug: Sotalol or Amiodarone

Class III anti-arrhythmic drug: Sotalol or amiodarone as per physician preference.

Recommended starting doses:

  • Sotalol: 80 mg BID per os, with a dose adjustment to once daily if the eGFR is between 40 and 60 mL/min.
  • Amiodarone: loading dose of 600 mg daily per os in divided doses for 1 week, followed by 400 mg daily per os in divided doses for 1 week, and subsequently 200 mg per os once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite safety outcome
Time Frame: 1 year
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year
Death from any cause
1 year
Severe adverse events leading to drug discontinuation
Time Frame: 1 year
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
1 year
Unscheduled hospitalisation for heart failure or acute coronary syndrome
Time Frame: 1 year
Unscheduled hospitalisation for heart failure or acute coronary syndrome
1 year
AF recurrence
Time Frame: 1 year
Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF)
1 year
Major adverse cardiovascular events
Time Frame: 1 year
Composite of cardiovascular death, myocardial infarction, stroke
1 year
Catheter ablation
Time Frame: 1 year
Incidence of catheter ablation for AF during follow-up
1 year
Cardiovascular hospitalisation duration
Time Frame: 1 year
Total number of days of cardiovascular hospitalisation
1 year
Treatment-related adverse events
Time Frame: 1 year

All serious adverse events and adverse events:

  • Frequency and severity of all treatment-emergent adverse events
  • Proportion of participants experiencing at least one AE/SAE.
  • Specific drug-related adverse events (e.g., QT prolongation, proarrhythmia, bradycardia, hypotension, fatigue, gastrointestinal disturbances).
1 year
Cardiac function - LVEF
Time Frame: 3 months
Changes in cardiac function assessed by left ventricular ejection fraction expressed in percentages (%) from baseline measured by echocardiography
3 months
NT-proBNP
Time Frame: 3 months
Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) at 3 months from baseline
3 months
QTc
Time Frame: 1 year
Change in QTc interval (ms) and QRS duration (ms) from baseline
1 year
Healthcare resource utilization
Time Frame: 1 year
Total within-trial healthcare resource utilization expressed in Euro (€)
1 year
Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Time Frame: 1 year
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)
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year

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
Time Frame: 1 year
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Foundation Flanders

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S69367
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-525121-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Starting 12 months after publication

IPD Sharing Access Criteria

Upon reasonable request to the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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