Cytoflavin in Combination With Reperfusion in Stroke Patients

Polysan

Status: Completed

Conditions: Acute Stroke

Treatments: Drug: Control; Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)

Study type: Observational

Funder types: Industry

Identifiers

NCT05297851

CTF-STRobs-22

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Cytoflavin

Description:

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

Treatment:

Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)

Control

Description:

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.

Treatment:

Drug: Control