Flecainide safety in people with atrial fibrillation and stable coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial compares flecainide to standard rhythm-control therapies (sotalol or amiodarone) in adults with atrial fibrillation and stable coronary artery disease to see if flecainide has similar safety outcomes. Participants are assigned to receive either flecainide or a standard drug as part of routine care, with safety outcomes including serious adverse events, hospitalizations, and deaths. The study aims to determine non-inferiority of flecainide in terms of safety while maintaining rhythm control. Enrollment requires adults 18 or older with non-permanent AF or ectopic atrial tachycardia and defined stable CAD. The trial is conducted at multiple European sites with lead sponsorship from KU Leuven and collaboration with Research Foundation Flanders.

Why it matters

Who can join: the full rules

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:

  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.
* LVEF ≥ 45% documented on any imaging modality\*

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
* Clinically significant uncorrected hypokalemia or hypomagnesemia before initiation of trial treatment.
* Evidence or history of thyroid dysfunction contraindicating amiodarone use, where amiodarone would be prescribed as standard of care treatment.
* Hypersensitivity to the active substances or any excipients.
* 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
* Moderate or severe congenital heart disease as per 2020 ESC guidelines
* Hypertrophic cardiomyopathy (septal or posterior wall thickness \>1.5 cm)
* Significant chronic kidney disease (eGFR \<40 mL/min)
* Life expectancy less than 1 year
* 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
* 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.
* Participation in an interventional Trial with an investigational medicinal product (IMP) or device

Where it's running

• AZorg
  Aalst, Belgium Recruiting
• Universitair Ziekenhuis Antwerpen
  Edegem, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• AZ Turnhout
  Turnhout, Belgium Recruiting
• Imelda
  Bonheiden, Belgium Not yet recruiting
• AZ ST-JAN Brugge A.V.
  Bruges, Belgium Not yet recruiting

Study contacts

• Study coordinator: Joris Ector, MD PhD
• Email: Joris.Ector@UZLeuven.be
• Phone: +32 16 34 14 87

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.