Stroke, Acute, Stroke, Ischemic
Conditions
Keywords
stroke, сytoflavin
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
Interventions
DRUGCytoflavin
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
Sponsors
POLYSAN Scientific & Technological Pharmaceutical Company
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form 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
1. NIHSS 1a (coma) score 3 at the time of enrollment 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; | Base, day 14, day 21, day 90 | Modified Rankin Scale (mRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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); | Day 7, day 14, day 21, day 90 | National Institute of Health Stroke Scale (NIHSS) |
| 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 | Modified Rankin Scale (mRS) |
| Percentage of patients with repeated ACVA or TIA during the study; | Day 90 | Repeated ACVA or TIA |
| Percentage of patients with lethal outcome in the period of hospitalization and follow-up | Day 90 | Lethal outcome |
| 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 | Stroke-Specific Quality of Life Scale (SS-QOL) |
Countries
Russia
Contacts
Primary ContactAlexey Kovalenko, Doc Biol Sci
Outcome results
None listed