Cytoflavin in Combination With Reperfusion in Stroke Patients

March 16, 2023 updated by: POLYSAN Scientific & Technological Pharmaceutical Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Northern State Medical University of the Ministry of Health of the Russian Federation
      • Belgorod, Russian Federation
        • Belgorod Regional Clinical Hospital of St. Joasaph
      • Kazan, Russian Federation
        • Interregional Clinical and Diagnostic Center
      • Saint Petersburg, Russian Federation
        • City General Hospital №2
      • Saint Petersburg, Russian Federation
        • SPb GBUZ "City Hospital №26"
      • Saint Petersburg, Russian Federation
        • City Mariinsky Hospital
      • Saint-Petersburg, Russian Federation, 197706
        • City Hospital of the Holy Martyr Elizabeth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women 18-85 y.o. with acute stroke who receive reperfusion (intravenous thrombolysis and/or mechanical thrombectomy) and continue treatment in the acute stroke unit

Description

Inclusion Criteria:

  1. Signed Informed Consent;
  2. Men and women 18-85 y.o.;
  3. 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®;
  4. NIHSS score of at least 5 and less than 24;
  5. reperfusion therapy performed on admission;
  6. The size of the ischemic focus according to ASPECTS score >=6;
  7. Time from stroke onset to admission not exceeeding 6 hours;
  8. Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
  9. 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:

  1. Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
  2. Hemorrhagic stroke;
  3. Contraindications for CT scanning;
  4. Initial severe disability requiring assistance in everyday life before stroke;
  5. previous stroke with a residual neurological deficit;
  6. Severe comorbidity with a life expectancy of less than 6 months;
  7. 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);
  8. Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cytoflavin
Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and receive intravenous Cytoflavin® at a discretion of the physician, starting this treatment within the first 24 hours from the onset of stroke
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.
Control
Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and do not receive Cytoflavin as part of their routine clinical practice, but may receive any other neuroprotective medications.
Drug: Control
Standard treatment accordind to the routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with good functional outcome
Time Frame: 90 days
Proportion of patients who achieve score 0-2 by modified Rankin scale
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Investigators

  • Principal Investigator: Dina R Khasanova, prof., Interregional Clinical and Diagnostic Center, Kazan, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTF-STRobs-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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