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.
1 other identifier
observational
562
1 country
17
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedApril 18, 2025
July 1, 2024
1.6 years
July 17, 2024
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;
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
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);
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;
Day 14, day 21, day 90
Percentage of patients with repeated ACVA or TIA during the study;
Day 90
- +1 more secondary outcomes
Study Arms (2)
The test group
Basic therapy + Cytoflavin
The control group
Basic therapy (with or without other neuroprotector)
Interventions
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
Eligibility Criteria
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).
You may qualify if:
- Signed informed consent form
- Age from 18 years and older
- Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study
- Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and/or 6 at the time of starting the therapy ≥ 1))
- Conservative stroke treatment tactics (without reperfusion therapy thrombolysis/thrombus extraction)
- 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)
You may not qualify if:
- NIHSS 1a (coma) score 3 at the time of enrollment
- Initial severe disablement (corresponding to mRS \> 2) requiring external assistance in everyday life before development of stroke
- History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit
- Severe comorbidity with expected lifespan of not more than 6 months
- Pregnancy and breastfeeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
"Ivanovo Regional Clinical Hospital"
Ivanovo, Russia
Kazan State Medical University
Kazan', Russia
State Autonomous Institution of Health Interregional clinical diagnostic center
Kazan', Russia
Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)
Moscow, Russia
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
Vorohobov's City Clinical Hospital №67
Moscow, Russia
City Clinical Hospital No. 1 Novosibirsk
Novosibirsk, Russia
Alexandrovskaya hospital
Saint Petersburg, Russia
Almazov National Medical Research Centr
Saint Petersburg, Russia
City Mariinsky Hospital
Saint Petersburg, Russia
Nikolaevskaya Hospital
Saint Petersburg, Russia
Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine
Saint Petersburg, Russia
St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"
Saint Petersburg, Russia
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia
Smolensk Regional Clinical Hospital
Smolensk, Russia
Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan
Ufa, Russia
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 23, 2024
Study Start
March 1, 2024
Primary Completion
September 30, 2025
Study Completion
November 1, 2025
Last Updated
April 18, 2025
Record last verified: 2024-07