Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.
POLYSAN Scientific & Technological Pharmaceutical Company
562 participants
Mar 1, 2024
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- 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)
Exclusion Criteria6
- 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
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Interventions
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
Locations(17)
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NCT06514976