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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Win Medica Pharmaceutical S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

13 Apr 2023 → 31 Jan 2026

Decision date (initial)

2025-01-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

WinMedica S.A

External identifiers

EU CT number

2024-519233-33-00

EudraCT number

2022-002589-34

ClinicalTrials.gov

NCT05549752

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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.

Secondary objectives 1

1. To prove the superiority of flecainide over amiodarone in the following: ▪ the reduction of the hospitalizations from the Emergency Department due to AF ▪ the time required to successfully restore sinus rhythm ▪ reduction in the need to conduct electrical cardioversion

Conditions and MedDRA coding

Cardioversion of paroxysmal atrial fibrillation in the Emergency Department in patients with coronary artery disease without residual ischemia and an left ventricular ejection fraction > 35%

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age: 18-25 years old
2. 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.
3. 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.
4. Ejection fraction > 35% (documented by cardiac ultrasound in the Emergency Department or within the last year).
5. Signed informed consent form.

Exclusion criteria 17

1. 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.
2. Severe Chronic Kidney Disease (stage ≥ 4).
3. Severe systemic disease, including neoplastic disease under any antineoplasmatic treatment, liver failure, infection with fever.
4. 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.
5. Intolerance or known allergy to flecainide and amiodarone.
6. Pregnancy and/or breastfeeding.
7. Any previous 24-hour ECG halter monitoring with > 720 polymorphic PVCs / 24 hours, or non sustained ventricular tachycardia.
8. No history of coronary artery disease.
9. Myocardial infarction with ST-segment elevation.
10. 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.
11. Unstable angina (myocardial ischemia at rest or with minimal effort, absence of acute injury/ myocardial cell necrosis).
12. 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%.
13. History of acute coronary syndrome within one year.
14. Severe aortic valve stenosis (mean pressure difference> 40 mmHg, AVA < 1 cm/m2).
15. Participation in any other clinical trial.
16. Life expectancy less than 1 year.
17. Inapprooriate, unfit, or unwilling patient to follow the required protocol procedures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 6 hours].
2. The combined frequency of PVCs, NSVT, SVT, bradycardia < 50 bpm, and systolic blood pressure < 90 mmHg [from the moment the drug is administered and up to 6 hours].

Secondary endpoints 6

1. The frequency of discharges from the Emergency Department in sinus rhythm [from the moment the drug is administered and for a period of up to 6 hours].
2. The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 24 hours, 24-hour Holter monitoring].
3. Time to restoration to sinus rhythm [from the moment the drug is administered and for up to 6 hours].
4. The frequency of electrical cardioversion [from the moment the drug is administered and for up to 24 hours].
5. The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes [from the moment the drug is administered and for up to 24 hours].
6. The frequency, severity and type of AEs [from the moment the drug is administered and for up to 30 days].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Win Medica Pharmaceutical S.A.

Sponsor organisation

Win Medica Pharmaceutical S.A.

Address

35 Attiki Odos Turnoff 33, Idipodos 1-3 Idipodos 1-3

City

Chalandri

Postcode

152 38

Country

Greece

Scientific contact point

Organisation

Win Medica Pharmaceutical S.A.

Contact name

Giota Koufaki

Public contact point

Organisation

Win Medica Pharmaceutical S.A.

Contact name

Giota Koufaki

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications