Clinical Trial

A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. Efficacy and safety of Refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-01; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2026-04-07
Trial Details
NCT Number NCT06540352
Lead Sponsor National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions Atrial Fibrillation, Atrial Flutter
Enrollment 175 participants
Start Date 2024-06-03
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08