Cytoflavin in Combination With Reperfusion in Stroke Patients

Acute Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297851
• Other study ID #: CTF-STRobs-22
• Status: Completed
• Start date: April 10, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: POLYSAN Scientific & Technological Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2023
• Est. primary completion date: February 28, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Cerebral Infarction
• Stroke

Intervention

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
Standard treatment accordind to the routine clinical practice

Locations

Country	Name	City	State
Russian Federation	Northern State Medical University of the Ministry of Health of the Russian Federation	Arkhangel'sk
Russian Federation	Belgorod Regional Clinical Hospital of St. Joasaph	Belgorod
Russian Federation	Interregional Clinical and Diagnostic Center	Kazan
Russian Federation	City General Hospital ?2	Saint Petersburg
Russian Federation	City Mariinsky Hospital	Saint Petersburg
Russian Federation	SPb GBUZ "City Hospital ?26"	Saint Petersburg
Russian Federation	City Hospital of the Holy Martyr Elizabeth	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with good functional outcome	Proportion of patients who achieve score 0-2 by modified Rankin scale	90 days