NCT06514976 Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
| NCT ID | NCT06514976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
| Condition | Stroke, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 562 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 562 participants in total. It began in 2024-03-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06514976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06514976 currently recruiting?
Yes, NCT06514976 is actively recruiting participants. Contact the research team at science@polysan.ru for enrollment information.
Where is the NCT06514976 trial being conducted?
This trial is being conducted at Ivanovo, Russia, Kazan', Russia, Kazan', Russia, Moscow, Russia and 11 additional locations.
Who is sponsoring the NCT06514976 clinical trial?
NCT06514976 is sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. The trial plans to enroll 562 participants.
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