An observational study in Stroke, Acute and Stroke, Ischemic, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Recruiting at 17 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Observational
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
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 562 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
According to the routine clinical practice, the patient is scheduled to receive the treatment as per one of the following regimens:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Basic therapy + Cytoflavin
Drug: Cytoflavin
Basic therapy (with or without other neuroprotector)
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
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)
Time frame: Base, day 14, day 21, day 90
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)
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
Rivermead Scale
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);
National Institute of Health Stroke Scale (NIHSS)
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;
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Day 14, day 21, day 90
Percentage of patients with repeated ACVA or TIA during the study;
Repeated ACVA or TIA
Time frame: Day 90
Percentage of patients with lethal outcome in the period of hospitalization and follow-up
Lethal outcome
Time frame: Day 90
Started Mar 2024 (actual). Primary completion is estimated for Sep 2025, 18 months after the start.
Of 42 industry-sponsored observational studies under Ischemic Stroke, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 18 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
POLYSAN Scientific & Technological Pharmaceutical Company →