Flecainide versus amiodarone for cardioversion of recent paroxysmal atrial fibrillation in patients with treated 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 is a prospective, multicenter, randomized Phase 3 trial comparing IV flecainide to IV amiodarone for cardioversion of paroxysmal atrial fibrillation in the emergency department. Eligible patients are adults with recent-onset AF and a history of coronary artery disease without residual ischemia and left ventricular ejection fraction >35%. The trial aims to demonstrate superiority of flecainide for successful cardioversion (including time to cardioversion) while showing non-inferior safety compared with amiodarone. Participants are randomized to receive the assigned antiarrhythmic and monitored in the ED with standard cardiac and hemodynamic surveillance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-85 years old
2. Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:

   1. Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department
   2. Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, and patient has been on anticoagulation for at least 30 days
   3. History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:

      * PCI \<= 1 year, or
      * CABG \<= 3 years, or
      * Negative imaging-based stress testing within 1 year, and:

        * History of known coronary artery stenosis \> 60% without revascularization, or
        * PCI \>= 1 year, or
        * CABG \>= 3 years
3. Ejection Fraction \> 35% (documented by cardiac ultrasound at the Emergency Department, or within 1 year)
4. Signed informed consent from the patient or legal representative.

Exclusion Criteria:

1. Based on ECG at the Emergency Department:

   1. Atrial Flutter
   2. Newly documented Left Bundle Branch Block (LBBB)
   3. Newly documented Right Bundle Branch Block (RBBB) with QRS duration \> 150ms
2. Previously documented 24-hour ECG holter monitoring with \> 720 poly PVCs/24hours, or non sustained ventricular tachycardia
3. No history of coronary artery disease
4. ST-Segment Elevation Myocardial Infarction (STEMI)
5. Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:

   1. If troponin at t0h is over the "low" criterion on table of the cutoff values
   2. If the change of troponin (Δtroponin) at t1h is over the respective cutoff value at the table for the cutoff values
6. Unstable angina, defined as myocardial ischemia at rest or at minimum effort, in the absence of acute injury/necrosis of myocardial cells
7. Known residual ischemia:

   1. Positive imaging-based stress testing
   2. Negative imaging-based stress testing \>= 1 year, and:

      * History of known coronary artery stenosis \> 60% without revascularization, or
      * PCI \>= 1 year, or
      * CABG \>= 3 years
8. History of acute coronary syndrome within 1 year
9. Severe Aortic Valve Stenosis (mean pressure gradient \> 40mmHg, AVA \< 1cm/m\^2)
10. Severe Chronic Kidney Disease (stage \>= 4)
11. Severe systematic disease, including neoplasmatic disease under any antineoplasmatic treatment, liver failure, infection with fever
12. Use of strategy "pill in the pocket", by taking flecainide (max 200mg) or propafenone (max 600mg) within 6 hours prior to Emergency Department visit
13. Known dysanexia or allergy to flecainide or amiodarone
14. Pregnancy or/and breastfeeding
15. Participation in any other clinical trial
16. Life expectancy less than 1 year
17. Inappropriate, unfit, or unwilling to follow the desingated protocol procedures.

Where it's running

• First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens, Athens, Greece
  Athens, Greece Recruiting
• Konstantopoulio General Hospital
  Athens, Greece Recruiting
• KAT General Hospital
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Konstantinos P Tsioufis, Professor
• Email: ktsioufis@hippocratio.gr
• Phone: 2132088000

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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.