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

POLYSAN Scientific & Technological Pharmaceutical Company17 sites in 1 country562 target enrollmentMarch 1, 2024

ConditionsStroke, Acute Stroke, Ischemic

InterventionsCytoflavin

Overview

Phase: N/A
Intervention: Cytoflavin
Conditions: Stroke, Acute
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Enrollment: 562
Locations: 17
Primary Endpoint: 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;
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

November 1, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

The test group

Basic therapy + Cytoflavin

Intervention: Cytoflavin

Outcomes

Primary Outcomes

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

Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;(Day 14, day 21, day 90)
Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group(Day 7, day 14, day 21, day 90)
Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;(Day 14, day 21, day 90)
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);(Day 7, day 14, day 21, day 90)
Percentage of patients with repeated ACVA or TIA during the study;(Day 90)
Percentage of patients with lethal outcome in the period of hospitalization and follow-up(Day 90)