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Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).
EU CTIS ID: 2025-525121-13-00
What this study is testing
To demonstrate that, in patients with atrial fibrillation and stable coronary artery disease, the safety profile of flecainide for rhythm control is non-inferior to that of class III antiarrhythmic drugs, as measured by the primary composite endpoint over a minimum follow-up of 1 year.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 (ICF)
- 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 of ischemia, defined as: a. Prior percutaneous coronary intervention; OR b. Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR c. Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR d. 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.
- Left ventricular ejection fraction ≥ 45% documented on any imaging modality
You likely can't join if
- LVEF < 45%
- Significant chronic kidney disease (eGFR <40 mL/min)
- Life expectancy less than 1 year
- NYHA class III or IV congestive heart failure
- 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.
See the full eligibility criteria
Who can join
- 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 (ICF)
- 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 of ischemia, defined as: a. Prior percutaneous coronary intervention; OR b. Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR c. Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR d. 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.
- Left ventricular ejection fraction ≥ 45% documented on any imaging modality
What rules you out
- LVEF < 45%
- Significant chronic kidney disease (eGFR <40 mL/min)
- Life expectancy less than 1 year
- NYHA class III or IV congestive heart failure
- 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
- 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
- Known channelopathy, including Brugada syndrome, long QT syndrome,…
- 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
- 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.
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.