Ethacizine for Atrial fibrillation

Inclusion criteria

• {"criterion_text":"-1.\tMale or female patients, aged 18-70 years old inclusive at the time of signing the informed consent."}
• {"criterion_text":"-2.\tBody weight over 70 kg."}
• {"criterion_text":"-3.\tClinical paroxysmal or persistent atrial fibrillation confirmed by the surface 12-lead ECG or 24-h Holter monitoring."}
• {"criterion_text":"-4.\tFemales 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)."}
• {"criterion_text":"-5.\tSigned informed consent."}
• {"criterion_text":"-(for Phase II) 1.\tPatient 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."}
• {"criterion_text":"-(for Phase II) 2.\tPatient has to be on stable treatment regimen for atrial fibrillation."}

Exclusion criteria

• {"criterion_text":"-1.\tPatients with significant structural or functional heart disease: -\tleft ventricular hypertrophy (LVH): septum/ posterior wall ≥14 mm; -\tleft ventricular (LV) systolic dysfunction: LV EF ≤40%; -\tsevere aortic valve stenosis according criteria of ESC/EACTS Guidelines for the management of valvular heart disease; -\theart failure: NYHA functional class III or IV; -\tacute coronary syndrome, recent (3 months, or less) myocardial infarction with Q wave and/or convincingly significant myocardial damage; -\tsevere coronary artery disease without or incomplete revascularization."}
• {"criterion_text":"-10.\tClinically 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)."}
• {"criterion_text":"-11.\tEvidence of any significant clinical or laboratory finding, or test results that make it undesirable for the patient to participate in the study."}
• {"criterion_text":"-12.\tMalignancy of any location (if not in remision)."}
• {"criterion_text":"-13.\tAny 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."}
• {"criterion_text":"-14.\tContradiction for the use of the etacizin or propafenone as per Summary of Product Characteristics, including breast feeding."}
• {"criterion_text":"-15.\tProblems with information perception and/or completing the questionnaires."}
• {"criterion_text":"-16.\tPatients with alcohol or drug abuse."}
• {"criterion_text":"-17.\tPatients participating in another clinical trial currently or within 30 days before the enrolment (randomization)."}
• {"criterion_text":"-2.\tBMI > 30 kg/m2."}
• {"criterion_text":"-3.\tUncontrolled hypertension (grade III, SBP ≥180 mmHg and/or DBP ≥110 mmHg)."}
• {"criterion_text":"-4.\tSevere, stabile long-therm hypotension (SBP < 90 mmHg)."}
• {"criterion_text":"-5.\tSick-sinus syndrome or severe bradycardia less than < 50 beats per minute (average rate during 24 hours or conventional surface ECG)."}
• {"criterion_text":"-6.\t2nd- or 3rd-degree AV block or right or left bundle branch block, fixed and known Brugada syndrome."}
• {"criterion_text":"-7.\tProlonged QTc (> 460ms)."}
• {"criterion_text":"-8.\tImplanted pacemaker."}
• {"criterion_text":"-9.\tHyper or hypokalaemia."}

Primary endpoints

• {"endpoint_text":"-Recurrence of atrial fibrillation over 6 months of the treatment after restored sinus rhythm","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Proportion of participants with pharmacological cardioversion during Phase I","definition_or_measurement_approach":""}
• {"endpoint_text":"-The proportion of participants who meet clinical criteria for electrical cardioversion during Phase II","definition_or_measurement_approach":""}
• {"endpoint_text":"-Time of recurrence of atrial fibrillation during Phase II","definition_or_measurement_approach":""}
• {"endpoint_text":"-Change in Atrial fibrillation effect on quality of life from baseline to study end","definition_or_measurement_approach":""}
• {"endpoint_text":"-Rate of hospitalizations related to atrial fibrillation during Phase II","definition_or_measurement_approach":""}
• {"endpoint_text":"-A composite of cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke (MACE)","definition_or_measurement_approach":""}
• {"endpoint_text":"-The heart rate variabilty in treatment groups","definition_or_measurement_approach":""}

Latvia

Earliest CTIS Part Ii Submission Date

06-05-2025

Latest Decision Or Authorization Date

11-09-2025

Processing Time Days

128

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Olpha AS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Latvia