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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company

About this trial

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

Qualifiers

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))

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cytoflavin

Treatment groups

562 Participants
are divided into 2 treatment groups