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Completed

NCT Number: NCT05297851

Cytoflavin in Combination With Reperfusion in Stroke Patients

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern State Medical University of the Ministry of Health of the Russian Federation, Arkhangelsk, Russia

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent;
  • Men and women 18-85 y.o.;
  • A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
  • NIHSS score of at least 5 and less than 24;
  • reperfusion therapy performed on admission;
  • The size of the ischemic focus according to ASPECTS score >=6;
  • Time from stroke onset to admission not exceeeding 6 hours;
  • Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
  • Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor's instructions regarding drug therapy.

Exclusion criteria

  • Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
  • Hemorrhagic stroke;
  • Contraindications for CT scanning;
  • Initial severe disability requiring assistance in everyday life before stroke;
  • previous stroke with a residual neurological deficit;
  • Severe comorbidity with a life expectancy of less than 6 months;
  • Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);
  • Pregnancy or lactation

Treatment and study plan

Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)

Drug

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.

Control

Drug

Standard treatment accordind to the routine clinical practice

Primary outcomes

  1. Proportion of patients with good functional outcome

    Time frame: 90 days

    Proportion of patients who achieve score 0-2 by modified Rankin scale

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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