NCT06540352Active, not recruitingPhase 2
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
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg (Pharmproekt JSC) for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 1 Aug 2024
- Start date
- 3 Jun 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Diseases
- Atrial fibrillation
- NCT number
- NCT06540352
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 175
- From 3 Jun 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of class IA, IC and class III antiarrhythmic drugs less than 7 days (for amiodarone less than 60 days) before the study drug intake;
Other illness
- History of myocardial infarction or other structural heart disease;
Lab values
- QT prolongation over 500 ms.
Who the study is looking for
- Persistent form of AF/AFL lasting 7 days - 1 year (including patients who have previously undergone ineffective catheter or surgical ablation of AF or AFL and patients with a pacemaker or implanted cardioverter-defibrillator (ICD));
- Basic rhythm - AF and/or AFL according to the results of 12-lead ECG at randomization (Visit 2);
- Left ventricular ejection fraction (LVEF) \>40% according to the Simpson method;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.