Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06514976

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Ivanovo Regional Clinical Hospital", Ivanovo, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cytoflavin

Drug

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

Primary outcomes

  1. Percentage of patients with favorable functional outcome (score 0-2) according to Modified Rankin Scale (mRS) on Day of Discharge (assessment at Visit 4 or Visit 5, on Day of Discharge) and on Day 90;

    Time frame: Base, day 14, day 21, day 90

    Modified Rankin Scale (mRS)

Secondary outcomes

  1. Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;

    Time frame: Day 14, day 21, day 90

    Modified Rankin Scale (mRS)

  2. Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group

    Time frame: Day 7, day 14, day 21, day 90

    Rivermead Scale

  3. Change of the total score according to National Institute of Health Stroke Scale (NIHSS) on Day 3, Day 7, Day 14, and Day 21 as compared to the baseline level (Day 1);

    Time frame: Day 7, day 14, day 21, day 90

    National Institute of Health Stroke Scale (NIHSS)

  4. Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;

    Time frame: Day 14, day 21, day 90

    Stroke-Specific Quality of Life Scale (SS-QOL)

  5. Percentage of patients with repeated ACVA or TIA during the study;

    Time frame: Day 90

    Repeated ACVA or TIA

  6. Percentage of patients with lethal outcome in the period of hospitalization and follow-up

    Time frame: Day 90

    Lethal outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Alexey Kovalenko, Doc Biol Sci

CONTACT

[email protected]

+78127108225 ext. 212

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.