Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy

Last updated: April 15, 2025
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Blood Clots

Thrombosis

Treatment

Cytoflavin

Clinical Study ID

NCT06514976
CTF-NIS-2024
  • Ages > 18
  • All Genders

Study 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

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 6at the time of starting the therapy ≥ 1))

  5. Conservative stroke treatment tactics (without reperfusion therapythrombolysis/thrombus extraction)

  6. According to the routine clinical practice, the patient is scheduled to receive thetreatment 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 withoutneuroprotector)

Exclusion

Exclusion Criteria:

  1. NIHSS 1a (coma) score 3 at the time of enrollment

  2. Initial severe disablement (corresponding to mRS > 2) requiring external assistancein everyday life before development of stroke

  3. History of Parkinson's disease, dementia, multiple sclerosis, and other significantdiseases 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 patientineligible for participation in the study, restrict lawfulness of obtaining theinformed consent, or can influence the patient's ability to participate in the study

Study Design

Total Participants: 562
Treatment Group(s): 1
Primary Treatment: Cytoflavin
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
November 01, 2025

Connect with a study center

  • "Ivanovo Regional Clinical Hospital"

    Ivanovo,
    Russian Federation

    Active - Recruiting

  • Kazan State Medical University

    Kazan,
    Russian Federation

    Active - Recruiting

  • State Autonomous Institution of Health Interregional clinical diagnostic center

    Kazan,
    Russian Federation

    Active - Recruiting

  • Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)

    Moscow,
    Russian Federation

    Active - Recruiting

  • N.I. Pirogov City Clinical Hospital No. 1

    Moscow,
    Russian Federation

    Active - Recruiting

  • Vorohobov's City Clinical Hospital №67

    Moscow,
    Russian Federation

    Active - Recruiting

  • City Clinical Hospital No. 1 Novosibirsk

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • Alexandrovskaya hospital

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Centr

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • City Mariinsky Hospital

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Nikolaevskaya Hospital

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • The City Hospital of the Holy Martyr Elizabeth

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Smolensk Regional Clinical Hospital

    Smolensk,
    Russian Federation

    Active - Recruiting

  • Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan

    Ufa,
    Russian Federation

    Active - Recruiting

  • Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"

    Voronezh,
    Russian Federation

    Active - Recruiting

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