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A perspective multicenter randomized clinical trial for the safety and efficacy of flecainide compared to amiodorone for the conversion of paroxysmal atrial fibrillation in the Emergency Department in patients with coronary disease without residual ischemia and ejection fraction >35% (FLECA-ED)
EU CTIS ID: 2024-519233-33-00
What this study is testing
To prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal AF to sinus rhythm in the Emergency Department To prove that the safety of flecainide is non-inferior to amiodarone.
- Therapeutic confirmatory (Phase III)
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
- Age: 18-25 years old
- Paroxysmal atrial fibrillation (AF), documented by a 12-lead ECG, provided one of the following conditions is met: • Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department, regardless of anticoagulation therapy. • Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, with anticoagulation therapy for at least 30 days.
- History of coronary artery disease without residual ischemia, defined by one of the following criteria: • The patient underwent angioplasty within the past year. • The patient underwent coronary artery bypass surgery within the last 3 years. • The patient had a negative imaging-based stress testing within the past year, and additionally: • The patient had angioplasty more than a year ago, or • The patient underwent coronary artery bypass surgery more than 3 years ago, or • The patient has a history of coronary artery stenosis >60% without revascularization.
- Ejection fraction > 35% (documented by cardiac ultrasound in the Emergency Department or within the last year).
- Signed informed consent form.
You likely can't join if
- Based on the ECG in the Emergency Department. • Atrial Flutter • Newly documented Left Bundle Branch Block (LBBB) • Newly documented Right Bundle Branch Block (RBBB) with QRS duration > 150 ms.
- Myocardial infarction without ST-segment elevation • If the troponin level at t0 h is over the "low" criterion on the table of the cutoof values • If the change in troponin Delta (1-hour, Δtroponin at t1h ) is over the respective cutoff value at the table for the cutoff values.
- Unstable angina (myocardial ischemia at rest or with minimal effort, absence of acute injury/ myocardial cell necrosis).
- Known residual ischemia: • Positive imaging-based stress testing • Negative imaging-based stress testing ≥ 1 year, and : • The patient underwent vascularization more that one year ago , or • The patient underwent coronary artery bypass more than 3 years ago, or • The patient has a medical history of revascularization of stenosis coronary vessels more than 60%.
- History of acute coronary syndrome within one year.
- Severe aortic valve stenosis (mean pressure difference> 40 mmHg, AVA < 1 cm/m2).
See the full eligibility criteria
Who can join
- Age: 18-25 years old
- Paroxysmal atrial fibrillation (AF), documented by a 12-lead ECG, provided one of the following conditions is met: • Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department, regardless of anticoagulation therapy. • Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, with anticoagulation therapy for at least 30 days.
- History of coronary artery disease without residual ischemia, defined by one of the following criteria: • The patient underwent angioplasty within the past year. • The patient underwent coronary artery bypass surgery within the last 3 years. • The patient had a negative imaging-based stress testing within the past year, and additionally: • The patient had angioplasty more than a year ago, or • The patient underwent coronary artery bypass surgery more than 3 years ago, or • The patient has a history of coronary artery stenosis >60% without revascularization.
- Ejection fraction > 35% (documented by cardiac ultrasound in the Emergency Department or within the last year).
- Signed informed consent form.
What rules you out
- Based on the ECG in the Emergency Department. • Atrial Flutter • Newly documented Left Bundle Branch Block (LBBB) • Newly documented Right Bundle Branch Block (RBBB) with QRS duration > 150 ms.
- Myocardial infarction without ST-segment elevation • If the troponin level at t0 h is over the "low" criterion on the table of the cutoof values • If the change in troponin Delta (1-hour, Δtroponin at t1h ) is over the respective cutoff value at the table for the cutoff values.
- Unstable angina (myocardial ischemia at rest or with minimal effort, absence of acute injury/ myocardial cell necrosis).
- Known residual ischemia: • Positive imaging-based stress testing • Negative imaging-based stress testing ≥ 1 year, and : • The patient underwent vascularization more that one year ago , or • The patient underwent coronary artery bypass more than 3 years ago, or • The patient has a medical history of revascularization of stenosis coronary vessels more than 60%.
- History of acute coronary syndrome within one year.
- Severe aortic valve stenosis (mean pressure difference> 40 mmHg, AVA < 1 cm/m2).
- Participation in any other clinical trial.
- Life expectancy less than 1 year.
- Inapprooriate, unfit, or unwilling patient to follow the required protocol procedures.
- Severe Chronic Kidney Disease (stage ≥ 4).
- Severe systemic disease, including neoplastic disease under any antineoplasmatic treatment, liver failure, infection with fever.
- Use of the "pill in the pocket" strategy pocket with flecainide (max 200 mg) or propafenone (max 600 mg) within 6 hours before the visit in the Emergency Department.
- Intolerance or known allergy to flecainide and amiodarone.
- Pregnancy and/or breastfeeding.
- Any previous 24-hour ECG halter monitoring with > 720 polymorphic PVCs / 24 hours, or non sustained ventricular tachycardia.
- No history of coronary artery disease.
- Myocardial infarction with ST-segment elevation.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
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.