Status:
COMPLETED
Cytoflavin in Combination With Reperfusion in Stroke Patients
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Acute Stroke
Eligibility:
All Genders
18-85 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05297851
Start Date
April 10 2022
End Date
March 1 2023
Last Update
March 20 2023
Active Locations (7)
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1
Northern State Medical University of the Ministry of Health of the Russian Federation
Arkhangelsk, Russia
2
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, Russia
3
Interregional Clinical and Diagnostic Center
Kazan', Russia
4
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia, 197706