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Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation

ConditionsAtrial Fibrillation (AF)Coronary Artery Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Prior percutaneous coronary intervention; OR

Disqualifiers

LVEF < 45%

NYHA class III or IV congestive heart failure

Active treatment with amiodarone

History of intolerance of flecainide or both sotalol and amiodarone

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

988 Participants
are divided into 2 treatment groups
Group A: FlecainideExperimental treatment 1 intervention
Group B: Sotalol or AmiodaroneActive comparator 1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

All-cause mortality

Death from any cause

Time frame
1 year
2

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

Time frame
1 year
3

Unscheduled hospitalisation for heart failure or acute coronary syndrome

Unscheduled hospitalisation for heart failure or acute coronary syndrome

Time frame
1 year
4

AF recurrence

Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Research Foundation Flanders

Collaborator

Source ClinicalTrials.gov
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