Phase II clinical trial of refralon tablets in patients with persistent atrial fibrillation and atrial flutter. The structure and plan of the study

Refralon (cavutilide) is a highly effective drug for intravenous administration to restore sinus rhythm in patients with atrial fibrillation (AF) and atrial flutter (AFl) of any duration. Phase I clinical trial of tablets described pharmacokinetic profile of this drug, dosages and safety of therapy. These data underlie phase II clinical trial protocol as a multiple-center randomized double-blind placebo-controlled trial. This study is devoted to evaluate efficacy and safety of refralon tablets at doses of 1 and 2 mg daily to prevent AF/AFl recurrence after cardioversion of persistent form throughout 6-month therapy. This report is the first announcement of the study protocol (ClinialTrials.gov Identifier: NCT06540352).