Cytoflavin in Combination With Reperfusion in Stroke Patients

Completed

• Conditions: Acute Stroke
• Interventions: Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin); Drug: Control

• Registration Number: NCT05297851
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-04-10
• Primary Completion: 2023-02-28
• Status Verified: 2023-03
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cytoflavin	Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)	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
Control	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with good functional outcome	90 days	Proportion of patients who achieve score 0-2 by modified Rankin scale

Trial Locations

Locations (7)

Interregional Clinical and Diagnostic Center; 🇷🇺 Kazan, Russian Federation

City General Hospital №2; 🇷🇺 Saint Petersburg, Russian Federation

SPb GBUZ "City Hospital №26"; 🇷🇺 Saint Petersburg, Russian Federation

Belgorod Regional Clinical Hospital of St. Joasaph; 🇷🇺 Belgorod, Russian Federation

Northern State Medical University of the Ministry of Health of the Russian Federation; 🇷🇺 Arkhangel'sk, Russian Federation

City Hospital of the Holy Martyr Elizabeth; 🇷🇺 Saint-Petersburg, Russian Federation

City Mariinsky Hospital; 🇷🇺 Saint Petersburg, Russian Federation