Clinical trial NCT06514976: Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy
Official title: Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Stroke, Ischemic
Keywords: stroke
сytoflavin
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged above 18 years with diagnosis of ACVA of ischemic type who did not receive and are not scheduled for reperfusion therapy (thrombolysis, thrombus extraction).

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


Eligibility criteria: 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

Primary outcomes:
measure: 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;
timeFrame: Base, day 14, day 21, day 90
Secondary outcomes:
measure: Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;
timeFrame: Day 14, day 21, day 90
measure: Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group
timeFrame: Day 7, day 14, day 21, day 90
measure: 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);
timeFrame: Day 7, day 14, day 21, day 90
measure: Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;
timeFrame: Day 14, day 21, day 90
measure: Percentage of patients with repeated ACVA or TIA during the study;
timeFrame: Day 90
measure: Percentage of patients with lethal outcome in the period of hospitalization and follow-up
timeFrame: Day 90
Other outcomes:
Locations:
city: Ivanovo
country: Russian Federation
facility: "Ivanovo Regional Clinical Hospital"
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kazan
country: Russian Federation
facility: State Autonomous Institution of Health Interregional clinical diagnostic center
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov)
city: Moscow
country: Russian Federation
facility: N.I. Pirogov City Clinical Hospital No. 1
city: Moscow
country: Russian Federation
facility: Vorohobov's City Clinical Hospital №67
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital No. 1 Novosibirsk
city: Saint Petersburg
country: Russian Federation
facility: Alexandrovskaya hospital
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centr
city: Saint Petersburg
country: Russian Federation
facility: City Mariinsky Hospital
city: Saint Petersburg
country: Russian Federation
facility: Nikolaevskaya Hospital
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"
city: Saint Petersburg
country: Russian Federation
facility: The City Hospital of the Holy Martyr Elizabeth
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Ufa
country: Russian Federation
facility: Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan
city: Voronezh
country: Russian Federation
facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Study officials:
References: