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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Olpha AS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-09-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Olpha AS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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

Secondary objectives 6

1. To compare the rate of pharmacological cardioversion after up to one month of treatment
2. To compare the rate of indicated electrical cardioversion per treatment group over a 6 month of stable treatment regimen
3. To evaluate the time of AF recurrence, per treatment group
4. To evaluate the change in AF effect on quality of life from baseline to the study end, per treatment group
5. To compare the rate of major adverse cardiac events (MACE)
6. To evaluate the heart rate variabilty in treatment groups

Conditions and MedDRA coding

Atrial fibrillation

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Male or female patients, aged 18-70 years old inclusive at the time of signing the informed consent.
2. 2. Body weight over 70 kg.
3. 3. Clinical paroxysmal or persistent atrial fibrillation confirmed by the surface 12-lead ECG or 24-h Holter monitoring.
4. 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. 5. Signed informed consent.
6. (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.
7. (for Phase II) 2. Patient has to be on stable treatment regimen for atrial fibrillation.

Exclusion criteria 17

1. 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.
2. 2. BMI > 30 kg/m2.
3. 3. Uncontrolled hypertension (grade III, SBP ≥180 mmHg and/or DBP ≥110 mmHg).
4. 4. Severe, stabile long-therm hypotension (SBP < 90 mmHg).
5. 5. Sick-sinus syndrome or severe bradycardia less than < 50 beats per minute (average rate during 24 hours or conventional surface ECG).
6. 6. 2nd- or 3rd-degree AV block or right or left bundle branch block, fixed and known Brugada syndrome.
7. 7. Prolonged QTc (> 460ms).
8. 8. Implanted pacemaker.
9. 9. Hyper or hypokalaemia.
10. 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. 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. 12. Malignancy of any location (if not in remision).
13. 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. 14. Contradiction for the use of the etacizin or propafenone as per Summary of Product Characteristics, including breast feeding.
15. 15. Problems with information perception and/or completing the questionnaires.
16. 16. Patients with alcohol or drug abuse.
17. 17. Patients participating in another clinical trial currently or within 30 days before the enrolment (randomization).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Recurrence of atrial fibrillation over 6 months of the treatment after restored sinus rhythm

Secondary endpoints 7

1. Proportion of participants with pharmacological cardioversion during Phase I
2. The proportion of participants who meet clinical criteria for electrical cardioversion during Phase II
3. Time of recurrence of atrial fibrillation during Phase II
4. Change in Atrial fibrillation effect on quality of life from baseline to study end
5. Rate of hospitalizations related to atrial fibrillation during Phase II
6. A composite of cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke (MACE)
7. The heart rate variabilty in treatment groups

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Olpha AS

Sponsor organisation

Olpha AS

Address

Rupnicu Iela 5

City

Olaine

Postcode

2114

Country

Latvia

Scientific contact point

Organisation

Olpha AS

Contact name

Olpha

Public contact point

Organisation

Olpha AS

Contact name

Olpha

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

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

Documents 9 files

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

Application history

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