Status:
RECRUITING
Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT06514976
Start Date
March 1 2024
End Date
November 1 2025
Last Update
April 18 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
"Ivanovo Regional Clinical Hospital"
Ivanovo, Russia
2
Kazan State Medical University
Kazan', Russia
3
State Autonomous Institution of Health Interregional clinical diagnostic center
Kazan', Russia
4
Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)
Moscow, Russia