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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06540352

Enrollment

175

Registered

2024-08-06

Start date

2024-06-03

Completion date

2026-12-31

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Keywords

Refralon, Cavutilide, Niferidil, class III antiarrhythmic drug, new Russian drug, atrial fibrillation (AF), tablet, atrial flutter (AFL)

Brief 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.

Interventions

DRUG4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride

The drug Refralon® (n-1-\[(4-fluorophenyl)-2-(1-ethyl-4-piperidyl)-ethyl\]-4-nitrobenzamide hydrochloride) in the dosage form of a concentrate for the preparation of a solution for intravenous administration is registered for medical use in RF June 24, 2014, re-registration was successfully completed on November 20, 2019, registration certificate LP 002510, until December 31, 2025.

DRUGMannitol

Placebo in tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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;

Exclusion criteria

* 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; * History of myocardial infarction or other structural heart disease; * QT prolongation over 500 ms.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up;	6 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026