Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia

Last updated: March 27, 2023
Sponsor: Hippocration General Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Myocardial Ischemia

Heart Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT05549752
FLECA-ED
  • Ages 18-85
  • All Genders

Study Summary

Current guidelines for the cardioversion of paroxysmal Atrial Fibrillation at the Emergency Department do not prioritize between antiarrhythmic agents and do not consider the time taken for successful cardioversion. Furthermore, the use of flecainide -a class 1C antiarrhythmic agent- is contraindicated for the cardioversion of patients with revascularized coronary artery disease, as well as patients with ischemic cardiomyopathy and preserved ejection fraction. These recommendations stem from insufficient data, mainly from the CAST study.

The present study is a prospective, multicentre, randomized clinical trial. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation at the Emergency Department, and to prove that the safety of flecainide is non-inferior to amiodarone, in patients with coronary artery disease without residual ischemia and ejection fraction over 35%. The secondary goals of the study are to prove the superiority of flecainide over amiodarone in the reduction of hospitalizations from the Emergency Department due to atrial fibrillation, in the time taken to achieve cardioversion, and to the reduction of the need to conduct electrical cardioversion.

The study population will be all consecutive new-comers to the Emergency Department with primary diagnosis of paroxysmal atrial fibrillation and history of coronary artery disease without angina, without residual ischemia and with ejection fraction > 35%. The sample size will be 200 patients, who will be monitored for 30 days. At the Emergency Department, all patients will be under continuous ECG monitoring, and a 24-hour ECG device will also be placed (Holter). The patients will be randomized to the treatment group (flecainide) and the control group (amiodarone).

Patients in both arms will stay at the ED for a total of 6 hours after therapy initiation. If no adverse events occur in this time, the patient will be discharged from the ED. Otherwise, the patient will be admitted to the hospital. At 24 hours, the patients will visit the study centre for physical examination, ECG, cardiac ultrasound, 24-hour ECG removal and adverse events evaluation. At 30 days, follow-up via phone calls will be conducted for the evaluation of the study outcomes and adverse events.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 18-85 years old
  2. Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
  3. Atrial Fibrillation onset less than 48 hours from the time of presentation to theEmergency Department
  4. Atrial Fibrillation onset between 48 hours and 7 days from the time ofpresentation to the Emergency Department, and patient has been on anticoagulationfor at least 30 days
  5. History of Coronary Artery Disease without residual ischemia, defined by one ofthe 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% withoutrevascularization, or
  • PCI >= 1 year, or
  • CABG >= 3 years
  1. Ejection Fraction > 35% (documented by cardiac ultrasound at the Emergency Department,or within 1 year)
  2. Signed informed consent from the patient or legal representative.

Exclusion

Exclusion Criteria:

  1. Based on ECG at the Emergency Department:
  2. Atrial Flutter
  3. Newly documented Left Bundle Branch Block (LBBB)
  4. Newly documented Right Bundle Branch Block (RBBB) with QRS duration > 150ms
  5. Previously documented 24-hour ECG holter monitoring with > 720 poly PVCs/24hours, ornon sustained ventricular tachycardia
  6. No history of coronary artery disease
  7. ST-Segment Elevation Myocardial Infarction (STEMI)
  8. Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020guidelines on NSTEMI:
  9. If troponin at t0h is over the "low" criterion on table of the cutoff values
  10. If the change of troponin (Δtroponin) at t1h is over the respective cutoff valueat the table for the cutoff values
  11. Unstable angina, defined as myocardial ischemia at rest or at minimum effort, in theabsence of acute injury/necrosis of myocardial cells
  12. Known residual ischemia:
  13. Positive imaging-based stress testing
  14. 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
  1. History of acute coronary syndrome within 1 year
  2. Severe Aortic Valve Stenosis (mean pressure gradient > 40mmHg, AVA < 1cm/m^2)
  3. Severe Chronic Kidney Disease (stage >= 4)
  4. Severe systematic disease, including neoplasmatic disease under any antineoplasmatictreatment, liver failure, infection with fever
  5. Use of strategy "pill in the pocket", by taking flecainide (max 200mg) or propafenone (max 600mg) within 6 hours prior to Emergency Department visit
  6. Known dysanexia or allergy to flecainide or amiodarone
  7. Pregnancy or/and breastfeeding
  8. Participation in any other clinical trial
  9. Life expectancy less than 1 year
  10. Inappropriate, unfit, or unwilling to follow the desingated protocol procedures.

Study Design

Total Participants: 200
Study Start date:
March 24, 2023
Estimated Completion Date:
November 01, 2024

Connect with a study center

  • Athens Heart Center Amarousion

    Athens, Attiki 15125
    Greece

    Site Not Available

  • Attikon General Hospital of Athens

    Athens, 12462
    Greece

    Site Not Available

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

    Athens, 11527
    Greece

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.