Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation

NCT07405671 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: S693672025-525121-13
• Study Type: interventional
• Target: 988
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Coronary Artery Disease

Keywords

atrial fibrillation; rhythm control; stable coronary artery disease; flecainide; sotalol; amiodarone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• All-cause mortality

  1 year

• Severe adverse events leading to drug discontinuation

  1 year

• Unscheduled hospitalisation for heart failure or acute coronary syndrome

  1 year

• AF recurrence

  1 year

• Major adverse cardiovascular events

  1 year

Study Arms (2)

Flecainide

EXPERIMENTAL

Flecainide, a class Ic anti-arrhythmic drug.

Drug: flecainide

Sotalol or Amiodarone

ACTIVE COMPARATOR

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

Drug: Sotalol or Amiodarone

Interventions

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).

Flecainide

Sotalol or Amiodarone DRUG

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.

Sotalol or Amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Prior percutaneous coronary intervention; OR
• Prior revascularised ACS or coronary artery bypass surgery \> 3 months at enrolment; OR
• Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR
• 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.
• LVEF ≥ 45% documented on any imaging modality\*

You may not qualify if:

• LVEF \< 45%
• NYHA class III or IV congestive heart failure
• Active treatment with amiodarone
• History of intolerance of flecainide or both sotalol and amiodarone
• Unstable angina or inducible ischemia on exercise stress testing, myocardial perfusion imaging, stress cardiac MRI, or fractional flow reserve performed for clinical indications
• Baseline QRS duration ≥ 120 ms, unless a functioning pacemaker is present
• Baseline corrected QT interval (Fridericia) ≥ 500 ms
• Pre-existing advanced AV block (second-, or third-degree)
• Pre-existing sick sinus syndrome or sinus bradycardia \<50 bpm
• Known channelopathy
• Contra-indication to AV-slowing agents, including beta-blockers, diltiazem or verapamil
• Atrial fibrillation due to reversible cause
• Active intracardiac thrombus
• Acute coronary syndrome during the 3-month period preceding the consent date
• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Flecainide; Sotalol; Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Joris Ector, MD PhD

CONTACT

+32 16 34 14 87; Joris.Ector@UZLeuven.be

Bert Vandenberk, MD PhD MSc

CONTACT

bert.vandenberk@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, pragmatic, 2-arm, parallel group, open-label, individually randomised controlled non-inferiority trial

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 12 months after publication
• Access Criteria: Upon reasonable request to the Principal Investigator