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

Polysan

Status: Enrolling

Conditions: Stroke, Acute; Stroke, Ischemic

Treatments: Drug: Cytoflavin

Study type: Observational

Funder types: Industry

Identifiers

NCT06514976

CTF-NIS-2024

Details and patient eligibility

About

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

Enrollment: 562 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

562 participants in 2 patient groups

The test group

Description:

Basic therapy + Cytoflavin

Treatment:

Drug: Cytoflavin

The control group

Description:

Basic therapy (with or without other neuroprotector)