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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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 175
    • Site details revised
    v3
  2. Study title shortened, about 6 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06540352
Lead Sponsor National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions
(from sponsor)		 Atrial Fibrillation, Atrial Flutter
Related terms Atrial Fibrillation, Atrial Flutter
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov