About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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))
Disqualifiers
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
Trial 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).
Trial design
Case-control
Prospective
Treatments tested in this trial
Cytoflavin
DrugCytoflavin 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group
Rivermead Scale
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)
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)
Sponsors and contacts
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