Authorised Therapeutic use (Phase IV) Atrial fibrillation

An open-label, randomized clinical trial comparing Etacizin versus Propafenone in Atrial Fibrillation

EU CTIS ID: 2025-521267-13-01

What this study is testing

To evaluate the efficacy of etacizin for the maintenance of sinus rhythm in patients with atrial fibrillation, compared to propafenone over a 6-month treatment period

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male or female patients, aged 18-70 years old inclusive at the time of signing the informed consent.
2. Body weight over 70 kg.
3. Clinical paroxysmal or persistent atrial fibrillation confirmed by the surface 12-lead ECG or 24-h Holter monitoring.
4. Females of nonchildbearing potential (postmenopausal [defined as 12 months of spontaneous amenorrhea] or pre-menopausal with documented irreversible surgical sterilisation or hysterectomy) or childbearing potential (negative pregnancy test at screening and using an effective method to avoid pregnancy, i.e., oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device/intrauterine system, vasectomised sexual partner [with confirmed negative sperm counts] or true sexual abstinence).
5. Signed informed consent.
(for Phase II) 1. Patient qualifying for enrollment in Phase II (maintenance phase) has to be on sinus rhythm either in a result of pharmacological or pharmacological in combination with electrical cardioversion.

You likely can't join if

1. Patients with significant structural or functional heart disease: - left ventricular hypertrophy (LVH): septum/ posterior wall ≥14 mm; - left ventricular (LV) systolic dysfunction: LV EF ≤40%; - severe aortic valve stenosis according criteria of ESC/EACTS Guidelines for the management of valvular heart disease; - heart failure: NYHA functional class III or IV; - acute coronary syndrome, recent (3 months, or less) myocardial infarction with Q wave and/or convincingly significant myocardial damage; - severe coronary artery disease without or incomplete revascularization.
10. Clinically significant kidney or liver impairment (Chronic Kidney Disease assessed as eGFR < 45 ml/min/1.73 m², and liver impairment assessed as > 3x upper normal limit for AST and/or ALT).
11. Evidence of any significant clinical or laboratory finding, or test results that make it undesirable for the patient to participate in the study.
12. Malignancy of any location (if not in remision).
13. Any concomitant somatic or mental disease that is in a poor/un-controlled state, or, in opinion of the investigator, could bias the results of the trial, or increase the risk for adverse events.
14. Contradiction for the use of the etacizin or propafenone as per Summary of Product Characteristics, including breast feeding.

See the full eligibility criteria

Who can join

1. Male or female patients, aged 18-70 years old inclusive at the time of signing the informed consent.
2. Body weight over 70 kg.
3. Clinical paroxysmal or persistent atrial fibrillation confirmed by the surface 12-lead ECG or 24-h Holter monitoring.
4. Females of nonchildbearing potential (postmenopausal [defined as 12 months of spontaneous amenorrhea] or pre-menopausal with documented irreversible surgical sterilisation or hysterectomy) or childbearing potential (negative pregnancy test at screening and using an effective method to avoid pregnancy, i.e., oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device/intrauterine system, vasectomised sexual partner [with confirmed negative sperm counts] or true sexual abstinence).
5. Signed informed consent.
(for Phase II) 1. Patient qualifying for enrollment in Phase II (maintenance phase) has to be on sinus rhythm either in a result of pharmacological or pharmacological in combination with electrical cardioversion.
(for Phase II) 2. Patient has to be on stable treatment regimen for atrial fibrillation.

What rules you out

1. Patients with significant structural or functional heart disease: - left ventricular hypertrophy (LVH): septum/ posterior wall ≥14 mm; - left ventricular (LV) systolic dysfunction: LV EF ≤40%; - severe aortic valve stenosis according criteria of ESC/EACTS Guidelines for the management of valvular heart disease; - heart failure: NYHA functional class III or IV; - acute coronary syndrome, recent (3 months, or less) myocardial infarction with Q wave and/or convincingly significant myocardial damage; - severe coronary artery disease without or incomplete revascularization.
10. Clinically significant kidney or liver impairment (Chronic Kidney Disease assessed as eGFR < 45 ml/min/1.73 m², and liver impairment assessed as > 3x upper normal limit for AST and/or ALT).
11. Evidence of any significant clinical or laboratory finding, or test results that make it undesirable for the patient to participate in the study.
12. Malignancy of any location (if not in remision).
13. Any concomitant somatic or mental disease that is in a poor/un-controlled state, or, in opinion of the investigator, could bias the results of the trial, or increase the risk for adverse events.
14. Contradiction for the use of the etacizin or propafenone as per Summary of Product Characteristics, including breast feeding.
15. Problems with information perception and/or completing the questionnaires.
16. Patients with alcohol or drug abuse.
17. Patients participating in another clinical trial currently or within 30 days before the enrolment (randomization).
2. BMI > 30 kg/m2.
3. Uncontrolled hypertension (grade III, SBP ≥180 mmHg and/or DBP ≥110 mmHg).
4. Severe, stabile long-therm hypotension (SBP < 90 mmHg).
5. Sick-sinus syndrome or severe bradycardia less than < 50 beats per minute (average rate during 24 hours or conventional surface ECG).
6. 2nd- or 3rd-degree AV block or right or left bundle branch block, fixed and known Brugada syndrome.
7. Prolonged QTc (> 460ms).
8. Implanted pacemaker.
9. Hyper or hypokalaemia.

The study team makes the final eligibility decision.

Where it's taking place

Ukraine

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ukraine. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease Stroke Stroke recovery Peripheral artery disease Pulmonary hypertension

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.