NCT05297851

Cytoflavin in Combination With Reperfusion in Stroke Patients

Non-interventional Prospective Observational Study of Efficacy and Safety of Cytoflavin in Combination With Reperfusion Compared to Treatment With Other Neuroprotective Drugs Used in Routine Clinical Practice in Patients With Cerebral Infarction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DRUG	Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)	10 ml diluted to 100-200 ml of 5-10% dextroseor 0.9% sodium chloride solution. The rate of administration is 3-4 ml / min. The drug is administered in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, a single dose is increased to 20 ml.
DRUG	Control	Standard treatment accordind to the routine clinical practice

Timeline

• Start date: 2022-04-10
• Primary completion: 2023-02-28
• Completion: 2023-03-01
• First posted: 2022-03-28
• Last updated: 2023-03-20

Locations

7 sites across 1 country: Russia