Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
NCT ID: NCT06514976
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
562 participants
OBSERVATIONAL
2024-03-01
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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The test group
Basic therapy + Cytoflavin
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)
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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POLYSAN Scientific & Technological Pharmaceutical Company
INDUSTRY
Responsible Party
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Locations
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"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
Countries
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Central Contacts
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Other Identifiers
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CTF-NIS-2024
Identifier Type: -
Identifier Source: org_study_id
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