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Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation

NCT07405671 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 988

Last updated 2026-02-12

No results posted yet for this study

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

Interventions

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).

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.

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-12-31
Completion
2029-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405671 on ClinicalTrials.gov