Clinical trial NCT05297851: Cytoflavin in Combination With Reperfusion in Stroke Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Keywords: acute stroke
cerebral infarction
neuroprotection
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with good functional outcome
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: Northern State Medical University of the Ministry of Health of the Russian Federation
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Clinical Hospital of St. Joasaph
city: Kazan
country: Russian Federation
facility: Interregional Clinical and Diagnostic Center
city: Saint Petersburg
country: Russian Federation
facility: City General Hospital №2
city: Saint Petersburg
country: Russian Federation
facility: City Mariinsky Hospital
city: Saint Petersburg
country: Russian Federation
facility: SPb GBUZ "City Hospital №26"
city: Saint-Petersburg
country: Russian Federation
facility: City Hospital of the Holy Martyr Elizabeth
Study officials:
affiliation: Interregional Clinical and Diagnostic Center, Kazan, Russia
name: Dina R Khasanova, prof.
role: PRINCIPAL_INVESTIGATOR
References: