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

Recruiting

• Conditions: Stroke, Acute; Stroke, Ischemic
• Interventions: Drug: Cytoflavin

• Registration Number: NCT06514976
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 562

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The test group	Cytoflavin	Basic therapy + Cytoflavin

Primary Outcome Measures

Name	Time	Method
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;	Base, day 14, day 21, day 90	Modified Rankin Scale (mRS)

Secondary Outcome Measures

Name	Time	Method
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	Modified Rankin Scale (mRS)
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	Rivermead Scale
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	Stroke-Specific Quality of Life Scale (SS-QOL)
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	National Institute of Health Stroke Scale (NIHSS)
Percentage of patients with repeated ACVA or TIA during the study;	Day 90	Repeated ACVA or TIA
Percentage of patients with lethal outcome in the period of hospitalization and follow-up	Day 90	Lethal outcome

Trial Locations

Locations (17)

City Mariinsky Hospital; 🇷🇺 Saint Petersburg, Russian Federation

Alexandrovskaya hospital; 🇷🇺 Saint Petersburg, Russian Federation

"Ivanovo Regional Clinical Hospital"; 🇷🇺 Ivanovo, Russian Federation

The City Hospital of the Holy Martyr Elizabeth; 🇷🇺 Saint Petersburg, Russian Federation

State Autonomous Institution of Health Interregional clinical diagnostic center; 🇷🇺 Kazan, Russian Federation

Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"; 🇷🇺 Voronezh, Russian Federation

Kazan State Medical University; 🇷🇺 Kazan, Russian Federation

N.I. Pirogov City Clinical Hospital No. 1; 🇷🇺 Moscow, Russian Federation

Moscow City Clinical Hospital No.64 (CCH named after V.V. Vinogradov); 🇷🇺 Moscow, Russian Federation

City Clinical Hospital No. 1 Novosibirsk; 🇷🇺 Novosibirsk, Russian Federation

Vorohobov's City Clinical Hospital №67; 🇷🇺 Moscow, Russian Federation

Saint-Petersburg I. I. Dzhanelidze research institute of emergency medicine; 🇷🇺 Saint Petersburg, Russian Federation

Nikolaevskaya Hospital; 🇷🇺 Saint Petersburg, Russian Federation

St. Petersburg State Budgetary Institution of Public Health "City Hospital No. 40 of Kurortny District"; 🇷🇺 Saint Petersburg, Russian Federation

Smolensk Regional Clinical Hospital; 🇷🇺 Smolensk, Russian Federation

Almazov National Medical Research Centr; 🇷🇺 Saint Petersburg, Russian Federation

Municipal Clinical Hospital #13, the City of Ufa, State Budgetary Healthcare Institution of the Republic of Bashkortostan; 🇷🇺 Ufa, Russian Federation