Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
NCT Number: NCT06514976
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke, Acute|Stroke, Ischemic
Interventions: DRUG: Cytoflavin
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 562
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: "Ivanovo Regional Clinical Hospital", Ivanovo, Russian Federation|Kazan State Medical University, Kazan, Russian Federation|State Autonomous Institution of Health Interregional clinical diagnostic center, Kazan, Russian Federation|Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov), Moscow, Russian Federation|N.I. Pirogov City Clinical Hospital No. 1, Moscow, Russian Federation|Vorohobov's City Clinical Hospital №67, Moscow, Russian Federation|City Clinical Hospital No. 1 Novosibirsk, Novosibirsk, Russian Federation|Alexandrovskaya hospital, Saint Petersburg, Russian Federation|Almazov National Medical Research Centr, Saint Petersburg, Russian Federation|City Mariinsky Hospital, Saint Petersburg, Russian Federation|Nikolaevskaya Hospital, Saint Petersburg, Russian Federation|Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine, Saint Petersburg, Russian Federation|St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District", Saint Petersburg, Russian Federation|The City Hospital of the Holy Martyr Elizabeth, Saint Petersburg, Russian Federation|Smolensk Regional Clinical Hospital, Smolensk, Russian Federation|Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan, Ufa, Russian Federation|Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1", Voronezh, Russian Federation

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

Primary Outcome Measures: 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;, Modified Rankin Scale (mRS), Base, day 14, day 21, day 90
Secondary Outcome Measures: Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;, Modified Rankin Scale (mRS), 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, Rivermead Scale, Day 7, 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);, National Institute of Health Stroke Scale (NIHSS), 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;, Stroke-Specific Quality of Life Scale (SS-QOL), Day 14, day 21, day 90|Percentage of patients with repeated ACVA or TIA during the study;, Repeated ACVA or TIA, Day 90|Percentage of patients with lethal outcome in the period of hospitalization and follow-up, Lethal outcome, Day 90