Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05297851
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent;
2. Men and women 18-85 y.o.;
3. A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
4. NIHSS score of at least 5 and less than 24;
5. reperfusion therapy performed on admission;
6. The size of the ischemic focus according to ASPECTS score \>=6;
7. Time from stroke onset to admission not exceeeding 6 hours;
8. Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
9. Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor's instructions regarding drug therapy.
Exclusion Criteria:
1. Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
2. Hemorrhagic stroke;
3. Contraindications for CT scanning;
4. Initial severe disability requiring assistance in everyday life before stroke;
5. previous stroke with a residual neurological deficit;
6. Severe comorbidity with a life expectancy of less than 6 months;
7. Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);
8. Pregnancy or lactation
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05297851
Study Brief:
Protocol Section:
NCT05297851