Status:
RECRUITING
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
Lead Sponsor:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 preve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06540352
Start Date
June 3 2024
End Date
December 31 2025
Last Update
August 22 2024
Active Locations (1)
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1
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization
Moscow, Russia