Stroke, AcuteNCT06514976
Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
An observational study of Stroke, Acute and Stroke, Ischemic, run by POLYSAN Scientific & Technological Pharmaceutical Company at 17 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Cytoflavin
- Type of treatment
- Injection or infusion
- How many people
- 562 participants
- Where
- 17 sitesRussia
- Study dates
- 1 Mar 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Russia17 sites, 17 recruiting
- Recruiting
"Ivanovo Regional Clinical Hospital"
Ivanovo
- Recruiting
Kazan State Medical University
Kazan'
- Recruiting
State Autonomous Institution of Health Interregional clinical diagnostic center
Kazan'
- Recruiting
Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)
Moscow
- Recruiting
N.I. Pirogov City Clinical Hospital No. 1
Moscow
- Recruiting
Vorohobov's City Clinical Hospital №67
Moscow
- Recruiting
City Clinical Hospital No. 1 Novosibirsk
Novosibirsk
- Recruiting
Alexandrovskaya hospital
Saint Petersburg
- Recruiting
Almazov National Medical Research Centr
Saint Petersburg
- Recruiting
City Mariinsky Hospital
Saint Petersburg
- Recruiting
Nikolaevskaya Hospital
Saint Petersburg
- Recruiting
Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine
Saint Petersburg
- Recruiting
St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"
Saint Petersburg
- Recruiting
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg
- Recruiting
Smolensk Regional Clinical Hospital
Smolensk
- Recruiting
Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan
Ufa
- Recruiting
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh
About this study
Official title: 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
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Being tested
- Cytoflavin
- Keywords
- stroke, сytoflavin
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoflavinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| The test group | Basic therapy + Cytoflavin Receives: Drug: Cytoflavin | |
| The control group | Basic therapy (with or without other neuroprotector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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;
Modified Rankin Scale (mRS)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Day 14, day 21, day 90
Percentage of patients with repeated ACVA or TIA during the study;
Repeated ACVA or TIA
Measured: Day 90
Percentage of patients with lethal outcome in the period of hospitalization and follow-up
Lethal outcome
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514976
- Sponsor's protocol ID
- CTF-NIS-2024
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.
- ClinicalTrials.gov ID
- NCT06514976
- Acronym / sponsor ID
- CTF-NIS-2024
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- stroke, сytoflavin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The test group | – | Drug: CytoflavinBasic therapy + Cytoflavin |
| The control group | – | –Basic therapy (with or without other neuroprotector) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoflavinCytoflavin 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 | Drug | The test group |
Primary outcome
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;
Time frame: Base, day 14, day 21, day 90
Modified Rankin Scale (mRS)
6 secondary outcomes
Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;
Time frame: 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
Time frame: 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);
Time frame: 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;
Time frame: Day 14, day 21, day 90
Percentage of patients with repeated ACVA or TIA during the study;
Time frame: Day 90
Percentage of patients with lethal outcome in the period of hospitalization and follow-up
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Stroke, Ischemic, run by POLYSAN Scientific & Technological Pharmaceutical Company at 17 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexey Kovalenko, Doc Biol Sci (+78127108225 ext. 212, science@polysan.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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; (time frame: Base, day 14, day 21, day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.