Atrial Fibrillation ParoxysmalPhase 3FLECA-EDNCT05549752
Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia
A Phase 3 study testing Flecainide Injectable Solution and Amiodarone Injectable Solution in people with Atrial Fibrillation Paroxysmal and Coronary Artery Disease Without Residual Ischemia, run by Hippocration General Hospital at 3 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Coronary Artery Disease Without Residual Ischemia
- What is being tested?
- Flecainide Injectable Solution and Amiodarone Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGreece
- Study dates
- 24 Mar 2023to 30 Jan 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-85 years old
- Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
- Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department
- 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
- History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:
- PCI <= 1 year, or
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- 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
- Ejection Fraction > 35% (documented by cardiac ultrasound at the Emergency Department, or within 1 year)
- Signed informed consent from the patient or legal representative.
Who cannot join
- Based on ECG at the Emergency Department:
- Atrial Flutter
- Newly documented Left Bundle Branch Block (LBBB)
- Newly documented Right Bundle Branch Block (RBBB) with QRS duration > 150ms
- Previously documented 24-hour ECG holter monitoring with > 720 poly PVCs/24hours, or non sustained ventricular tachycardia
- No history of coronary artery disease
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- ST-Segment Elevation Myocardial Infarction (STEMI)
- Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:
- If troponin at t0h is over the "low" criterion on table of the cutoff values
- If the change of troponin (Δtroponin) at t1h is over the respective cutoff value at the table for the cutoff values
- Unstable angina, defined as myocardial ischemia at rest or at minimum effort, in the absence of acute injury/necrosis of myocardial cells
- Known residual ischemia:
- Positive imaging-based stress testing
- 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
- History of acute coronary syndrome within 1 year
- Severe Aortic Valve Stenosis (mean pressure gradient > 40mmHg, AVA < 1cm/m^2)
- Severe Chronic Kidney Disease (stage >= 4)
- Severe systematic disease, including neoplasmatic disease under any antineoplasmatic treatment, liver failure, infection with fever
- Use of strategy "pill in the pocket", by taking flecainide (max 200mg) or propafenone (max 600mg) within 6 hours prior to Emergency Department visit
- Known dysanexia or allergy to flecainide or amiodarone
- Pregnancy or/and breastfeeding
- Participation in any other clinical trial
- Life expectancy less than 1 year
- Inappropriate, unfit, or unwilling to follow the desingated protocol procedures.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece3 sites, 3 recruiting
- Recruiting
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens, Athens, Greece
Athens, 11527
Konstantinos P Tsioufis, Professor, 2132088000 ext. 8099, ktsioufis@hippocratio.gr
Konstantinos P Tsioufis, Professor
- Recruiting
Konstantopoulio General Hospital
Athens, 14233
Sotirios Patsilinakos, 2132057715, spatsilinakos@gmail.com
- Recruiting
KAT General Hospital
Athens, 14561
Nikolaos Kafkas, 2132086190, kardiosec@kat-hosp.gr
About this study
Official title: Safety and Efficacy of Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction > 35%
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.
Read more
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.
- Being tested
- Flecainide Injectable Solution, Amiodarone Injectable Solution
- Keywords
- Flecainide, Amiodarone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flecainide Injectable SolutionDrug
Intravenous Flecainide at a dose of 2.0mg/kg (maximum dose: 150mg) in 100ml D/W 5% for 10 minutes.
Amiodarone Injectable SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Flecainide | Active comparator | Not described Receives: Drug: Flecainide Injectable Solution |
| Amiodarone | Active comparator | Not described Receives: Drug: Amiodarone Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of successful cardioversion to sinus rhythm
Measured: 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.
Measured: From the drug initiation and for 6 hours
Secondary outcomes (6)
The frequency of patient discharges from the Emergency Department in sinus rhythm
Measured: From the drug initiation and for 6 hours
The frequency of successful cardioversion to sinus rhythm
Measured: From the drug initiation and for 24 hours, 24 hour ECG Holter monitoring
The time until the cardioversion to sinus rhythm
Measured: From the drug initiation and for 6 hours
The frequency of electrical cardioversion
Measured: From the drug initiation and for 24 hours
The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes
Measured: From the drug initiation and for 24 hours
The frequency, severity and type of Adverse Events
Measured: From the drug initiation and for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start24 Mar 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Win Medica, Pharmassist Ltd
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549752
- Sponsor's protocol ID
- FLECA-ED
- Acronym
- FLECA-ED
- Status last verified
- Jun 2025
- First submitted
- 18 Sep 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction > 35%
- ClinicalTrials.gov ID
- NCT05549752
- Acronym / sponsor ID
- FLECA-ED / FLECA-ED
- Keywords
- Flecainide, Amiodarone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Collaborators
- Win Medica, Pharmassist Ltd
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flecainide | Active comparator | Drug: Flecainide Injectable Solution |
| Amiodarone | Active comparator | Drug: Amiodarone Injectable Solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18-85 years old
- Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
- Ejection Fraction > 35% (documented by cardiac ultrasound at the Emergency Department, or within 1 year)
- Signed informed consent from the patient or legal representative.
Key exclusion criteria (27 listed)
- Based on ECG at the Emergency Department:
- Previously documented 24-hour ECG holter monitoring with > 720 poly PVCs/24hours, or non sustained ventricular tachycardia
- No history of coronary artery disease
- ST-Segment Elevation Myocardial Infarction (STEMI)
- Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flecainide Injectable SolutionIntravenous Flecainide at a dose of 2.0mg/kg (maximum dose: 150mg) in 100ml D/W 5% for 10 minutes. | Drug | Flecainide |
| Amiodarone Injectable SolutionIntravenous 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. | Drug | Amiodarone |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flecainide Injectable Solution and Amiodarone Injectable Solution in people with Atrial Fibrillation Paroxysmal and Coronary Artery Disease Without Residual Ischemia, run by Hippocration General Hospital at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos P Tsioufis, Professor (2132088000, ktsioufis@hippocratio.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of successful cardioversion to sinus rhythm (time frame: From the drug initiation and for 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.