Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy

Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.

Stroke remains one of the main socially significant problems in the healthcare in the third millennium. The lethality in persons with history of stroke by the end of the 1st year of disease is high. A trend to increased frequency of stroke in the young age is observed during the last decade; third of patients is working-age individuals, out of whom only 15-20% returns to labor, and others remain disabled persons requiring constant medical and social support

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Drug: Cytoflavin

• Study Type: Observational
• Enrollment (Estimated): 562

Contacts and Locations

• Study Contact: Name: Alexey Kovalenko, Doc Biol Sci; Phone Number: 212 +78127108225; Email: science@polysan.ru

Study Locations

• Russian Federation
  • Ivanovo, Russian Federation
    • Recruiting
    • "Ivanovo Regional Clinical Hospital"
  • Kazan, Russian Federation
    • Recruiting
    • Kazan State Medical University
  • Kazan, Russian Federation
    • Recruiting
    • State Autonomous Institution of Health Interregional clinical diagnostic center
  • Moscow, Russian Federation
    • Recruiting
    • Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)
  • Moscow, Russian Federation
    • Recruiting
    • N.I. Pirogov City Clinical Hospital No. 1
  • Moscow, Russian Federation
    • Recruiting
    • Vorohobov's City Clinical Hospital №67
  • Novosibirsk, Russian Federation
    • Recruiting
    • City Clinical Hospital No. 1 Novosibirsk
  • Saint Petersburg, Russian Federation
    • Recruiting
    • City Mariinsky Hospital
  • Saint Petersburg, Russian Federation
    • Recruiting
    • The City Hospital of the Holy Martyr Elizabeth
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Alexandrovskaya Hospital
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Almazov National Medical Research Centr
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Nikolaevskaya Hospital
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine
  • Saint Petersburg, Russian Federation
    • Recruiting
    • St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"
  • Smolensk, Russian Federation
    • Recruiting
    • Smolensk Regional Clinical Hospital
  • Ufa, Russian Federation
    • Recruiting
    • Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan
  • Voronezh, Russian Federation
    • Recruiting
    • Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged above 18 years with diagnosis of ACVA of ischemic type who did not receive and are not scheduled for reperfusion therapy (thrombolysis, thrombus extraction).

Description

Inclusion Criteria:

1. Signed informed consent form
2. Age from 18 years and older
3. Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study
4. Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and/or 6 at the time of starting the therapy ≥ 1))
5. Conservative stroke treatment tactics (without reperfusion therapy thrombolysis/thrombus extraction)

6. According to the routine clinical practice, the patient is scheduled to receive the treatment as per one of the following regimens:

   • Cytoflavin® 20-40 ml/day as a course of not less than 10 days or
   • another neuroprotector - course of not less than 10 days (or without neuroprotector)

Exclusion Criteria:

1. NIHSS 1a (coma) score 3 at the time of enrollment
2. Initial severe disablement (corresponding to mRS > 2) requiring external assistance in everyday life before development of stroke
3. History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit
4. Severe comorbidity with expected lifespan of not more than 6 months
5. Pregnancy and breastfeeding
6. Any other concomitant medical or serious psychic conditions, which make the patient ineligible for participation in the study, restrict lawfulness of obtaining the informed consent, or can influence the patient's ability to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The test group; Basic therapy + Cytoflavin	Drug: Cytoflavin; Cytoflavin solution for infusions. 20-40 ml/day (10 ml with the interval of 8-12 hours for 10 days; the single dose is increased up to 20 ml in case of the severe form of the disease) by intravenous drop infusion in dilution per 100-200 ml of 0.9% sodium chloride solution for 10 days; rate of administration: 3-4 ml/min
The control group; Basic therapy (with or without other neuroprotector)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with favorable functional outcome (score 0-2) according to Modified Rankin Scale (mRS) on Day of Discharge (assessment at Visit 4 or Visit 5, on Day of Discharge) and on Day 90;	Modified Rankin Scale (mRS)	Base, day 14, day 21, day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;	Modified Rankin Scale (mRS)	Day 14, day 21, day 90
Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group	Rivermead Scale	Day 7, day 14, day 21, day 90
Change of the total score according to National Institute of Health Stroke Scale (NIHSS) on Day 3, Day 7, Day 14, and Day 21 as compared to the baseline level (Day 1);	National Institute of Health Stroke Scale (NIHSS)	Day 7, day 14, day 21, day 90
Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;	Stroke-Specific Quality of Life Scale (SS-QOL)	Day 14, day 21, day 90
Percentage of patients with repeated ACVA or TIA during the study;	Repeated ACVA or TIA	Day 90
Percentage of patients with lethal outcome in the period of hospitalization and follow-up	Lethal outcome	Day 90

Collaborators and Investigators

• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: stroke; сytoflavin
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Ischemia
• Other Study ID Numbers: CTF-NIS-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No