A Randomized Open-Label Trial Comparing Ethacizine and Propafenone Hydrochloride for Sinus Rhythm Maintenance in Atrial Fibrillation Patients

The primary objective of this clinical trial is 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. This is clinically relevant as maintaining sinus rhythm is crucial in reducing the risk of stroke and improving the quality of life in patients with atrial fibrillation.

Secondary objectives include:

• Comparing the rate of pharmacological cardioversion after up to one month of treatment.
• Comparing the rate of indicated electrical cardioversion per treatment group over a 6-month stable treatment regimen.
• Evaluating the time of atrial fibrillation recurrence per treatment group.
• Assessing the change in the effect of atrial fibrillation on quality of life from baseline to the study end per treatment group.
• Comparing the rate of major adverse cardiac events (MACE).
• Evaluating heart rate variability in treatment groups.

The clinical trial involves a total of **74 participants** diagnosed with **atrial fibrillation**. The study population comprises both male and female subjects, aged between 18 and 70 years, with a body weight exceeding 70 kg. Participants were selected based on their clinical presentation of paroxysmal or persistent atrial fibrillation, confirmed through a surface 12-lead ECG or 24-hour Holter monitoring. The trial does not include a vulnerable population. Lifestyle factors such as diet and physical activity were not specified as part of the selection criteria. Key inclusion criteria required participants to be on a stable treatment regimen for atrial fibrillation and, for those in Phase II, to maintain sinus rhythm through pharmacological means or a combination of pharmacological and electrical cardioversion. Female participants of childbearing potential were required to have a negative pregnancy test at screening and to use effective contraceptive methods. The trial aims to evaluate the efficacy of etacizin in maintaining sinus rhythm compared to propafenone over a six-month treatment period.

The clinical trial is designed as an **open-label**, randomized study to evaluate the efficacy of **ethacizine** in maintaining sinus rhythm in patients with **atrial fibrillation**, compared to **propafenone** over a six-month treatment period. The trial will involve adult participants aged 18-70 years with a body weight over 70 kg, who have clinical paroxysmal or persistent atrial fibrillation confirmed by a 12-lead ECG or 24-hour Holter monitoring. The study will exclude individuals who do not meet these criteria. The primary endpoint is the recurrence of atrial fibrillation over the six-month treatment period after the restoration of sinus rhythm. Secondary endpoints include the proportion of participants requiring pharmacological or electrical cardioversion, changes in quality of life, hospitalization rates, and a composite of cardiovascular events.

Participants will be randomly assigned to receive either **ethacizine** or **propafenone**. The trial will be conducted over a maximum treatment period of 217 days, with the investigational products administered orally. The study will begin with a screening visit to confirm eligibility, followed by regular follow-up visits to monitor treatment efficacy and safety. The end-of-study visit will assess the final outcomes and any adverse events. Participants are expected to be involved in the study for the entire duration unless they experience significant adverse effects or choose to withdraw. Conditions that may lead to early termination include non-compliance with the study protocol or the occurrence of serious adverse events. The trial is categorized as low-intervention, with minimal additional procedures beyond standard clinical practice, ensuring a real-world assessment of clinical outcomes.

The clinical trial involves the administration of **Etacizine**, a pharmaceutical product formulated as a **film-coated tablet**. Each tablet contains 50 mg of the active substance **ethacizine**, a chemical compound. The medication is administered orally, with a maximum daily dose of 200 mg. The total maximum dose over the treatment period is 4.34 grams. The treatment duration is set for a maximum of 217 days. The trial aims to evaluate the efficacy of etacizine in maintaining sinus rhythm in patients with **atrial fibrillation**.

In comparison, the trial also includes the administration of **Propafenone Hydrochloride**, another antiarrhythmic agent. This compound is also administered orally, with a maximum daily dose of 900 mg and a total maximum dose of 19.53 grams over the same treatment period of 217 days. Propafenone serves as the comparator treatment in this open-label, randomized clinical trial. Both medications are chemically derived and are not formulated for pediatric use. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen.

The efficacy of the investigational medicinal product, **ethacizine**, will be assessed in a clinical trial comparing it to propafenone for the maintenance of sinus rhythm in patients with atrial fibrillation. The primary endpoint for evaluating efficacy is the recurrence of atrial fibrillation over a 6-month treatment period following the restoration of sinus rhythm. Secondary endpoints include the proportion of participants undergoing pharmacological cardioversion during Phase I, the proportion meeting clinical criteria for electrical cardioversion during Phase II, the time to recurrence of atrial fibrillation during Phase II, changes in the effect of atrial fibrillation on quality of life from baseline to study end, the rate of hospitalizations related to atrial fibrillation during Phase II, a composite measure of major adverse cardiovascular events (MACE) including cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke, and heart rate variability in treatment groups.

These efficacy parameters will be measured and collected using non-invasive investigations such as 24-hour Holter monitoring and 12-lead ECG, which are part of the trial's procedures. The trial is designed to have minimal impact on patients' normal healthcare, with these additional procedures posing minimal additional burden compared to standard clinical practice. The trial will be conducted over a 6-month period, with specific timepoints for assessments not explicitly detailed in the provided data.