Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation (NCT07405671) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
988 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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)