A Phase 3 interventional study of Flecainide Injectable Solution and Amiodarone Injectable Solution in Atrial Fibrillation Paroxysmal and Coronary Artery Disease Without Residual Ischemia, sponsored by Hippocration General Hospital. Recruiting at 3 sites in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Hippocration General Hospital · Phase 3, Interventional, and Treatment
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.
As of June 2025, an interim analysis has been completed, and preliminary study results have been submitted for presentation at the European Society of Cardiology (ESC) Congress. Based on the interim findings, the study's target sample size has been revised to a total of 80 patients.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hippocration General Hospital is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Paroxysmal Atrial Fibrillation, documented by 12-lead , with one of the following:
History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:
Negative imaging-based stress testing within 1 year, and:
Exclusion Criteria:
Based on at the Emergency Department:
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:
Known residual ischemia:
Negative imaging-based stress testing >= 1 year, and:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Flecainide Injectable Solution
Drug: Amiodarone Injectable Solution
Intravenous Flecainide at a dose of 2.0mg/kg (maximum dose: 150mg) in 100ml D/W 5% for 10 minutes.
Intravenous Amiodarone at a dose of 5.0-7.0 mg/kg for 1 hour, and maintenance dose of 50mg/h (maximum dose: 1000mg) for up to 24 hours.
The frequency of successful cardioversion to sinus rhythm
Time frame: From the drug initiation and for 6 hours
The combined frequency of premature ventricular contractions (PVCs), non-sustained ventricular tachycardia (NSVT), sustained ventricular tachycardia (SVT), bradycardia < 50bpm and systolic blood pressure < 90mmHg.
Time frame: From the drug initiation and for 6 hours
The frequency of patient discharges from the Emergency Department in sinus rhythm
Time frame: From the drug initiation and for 6 hours
The frequency of successful cardioversion to sinus rhythm
Time frame: From the drug initiation and for 24 hours, 24 hour ECG Holter monitoring
The time until the cardioversion to sinus rhythm
Time frame: From the drug initiation and for 6 hours
The frequency of electrical cardioversion
Time frame: From the drug initiation and for 24 hours
The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes
Time frame: From the drug initiation and for 24 hours
The frequency, severity and type of Adverse Events
Time frame: From the drug initiation and for 30 days
Plan to share: No
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Studies of the drugs tested here: Flecainide · Amiodarone
Hippocration General Hospital