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Clinical Trials in the EU / 2025-521267-13-01
Authorised Phase IV

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

2025-521267-13-01 · tracked via the Priya Life Science EU tracker
Sponsor
Olpha AS
Sponsor type
Pharmaceutical company
Therapeutic area
Cardiovascular Diseases
Decision date
11/09/2025
Enrollment target
30
Sites
Latvia

Condition studied

Atrial fibrillation

Investigational medicinal product(s)

Etacizīns 50 mg apvalkotās tabletesPROPAFENONE

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521267-13-01 on CTIS ↗ ← All trials in the EU