Cytoflavin in Combination With Reperfusion in Stroke Patients

NCT05297851 | Completed

• 1 other identifier: CTF-STRobs-22
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

acute stroke; cerebral infarction; neuroprotection

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with good functional outcome

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

  90 days

Study Arms (2)

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)

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

Interventions

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.

Cytoflavin

Control DRUG

Standard treatment accordind to the routine clinical practice

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (7)

Northern State Medical University of the Ministry of Health of the Russian Federation

Arkhangelsk, Russia

Location

Belgorod Regional Clinical Hospital of St. Joasaph

Belgorod, Russia

Location

Interregional Clinical and Diagnostic Center

Kazan', Russia

Location

City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, 197706, Russia

Location

City General Hospital №2

Saint Petersburg, Russia

Location

City Mariinsky Hospital

Saint Petersburg, Russia

Location

SPb GBUZ "City Hospital №26"

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction

Interventions

cytoflavin; Succinic Acid; Inosine; Niacinamide; Riboflavin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Flavins; Pteridines; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Dina R Khasanova, prof.

  Interregional Clinical and Diagnostic Center, Kazan, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: April 10, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

RU (7)