Evaluating Cytoflavin for Patients with Ischemic Stroke

Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.

This study is testing if Cytoflavin can help adults who have had an ischemic stroke recover better and reduce disability when they are not receiving other treatments.

Quick facts

• Study type: Observational
• Enrollment: 562 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (industry)
• Locations: 17 sites (Ivanovo and 16 other locations)
• Trial ID: NCT06514976 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficiency of Cytoflavin in patients who have experienced an ischemic stroke and are not receiving reperfusion therapy. Participants must be adults diagnosed with an acute ischemic stroke within 36 hours prior to enrollment and exhibit measurable motor deficits. The study will monitor the outcomes of patients receiving Cytoflavin as part of their conservative treatment regimen over a course of at least 10 days. The focus is on understanding the potential benefits of Cytoflavin in improving recovery and reducing disability in stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have suffered an acute ischemic stroke within the last 36 hours and have measurable motor deficits.

Not a fit: Patients with severe initial disability or those in a coma at the time of enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Cytoflavin in enhancing recovery and reducing disability in ischemic stroke patients.

How similar studies have performed: While the specific use of Cytoflavin in this context may be novel, similar studies evaluating neuroprotective agents in stroke patients have shown varying degrees of success.

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

Where this trial is running

Ivanovo and 16 other locations

• "Ivanovo Regional Clinical Hospital" — Ivanovo, Russia (RECRUITING)
• Kazan State Medical University — Kazan', Russia (RECRUITING)
• State Autonomous Institution of Health Interregional clinical diagnostic center — Kazan', Russia (RECRUITING)
• Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov) — Moscow, Russia (RECRUITING)
• N.I. Pirogov City Clinical Hospital No. 1 — Moscow, Russia (RECRUITING)
• Vorohobov's City Clinical Hospital №67 — Moscow, Russia (RECRUITING)
• City Clinical Hospital No. 1 Novosibirsk — Novosibirsk, Russia (RECRUITING)
• Alexandrovskaya hospital — Saint Petersburg, Russia (RECRUITING)
• Almazov National Medical Research Centr — Saint Petersburg, Russia (RECRUITING)
• City Mariinsky Hospital — Saint Petersburg, Russia (RECRUITING)
• Nikolaevskaya Hospital — Saint Petersburg, Russia (RECRUITING)
• Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine — Saint Petersburg, Russia (RECRUITING)
• St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District" — Saint Petersburg, Russia (RECRUITING)
• The City Hospital of the Holy Martyr Elizabeth — Saint Petersburg, Russia (RECRUITING)
• Smolensk Regional Clinical Hospital — Smolensk, Russia (RECRUITING)
• Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan — Ufa, Russia (RECRUITING)
• Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1" — Voronezh, Russia (RECRUITING)

Study contacts

• Study coordinator: Alexey Kovalenko, Doc Biol Sci

Conditions: Stroke, Acute, Stroke, Ischemic, stroke, сytoflavin