The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

Inclusion Criteria:

1. Written informed consent was obtained from the patient or their legally authorizedrepresentative prior to study participation.

2. Age 35-80.

3. Patients must exhibit neurological manifestations consistent with acute ischemicstroke, with a documented onset-to-intervention interval ranging from 24 to 72 hoursat the time of scheduled initial administration of the investigational drug.

4. Verified by CT/MRI current hemispheric ischemic stroke.

5. NIHSS score ≥5 and ≤15 at screening.

6. Ability to comply with all protocol-specified procedures, prohibitions, andrestrictions.

7. Willingness and ability to adhere to highly effective contraceptive methods asoutlined in the study protocol.

Exclusion Criteria:

1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic braininjuries

2. Vertebrobasilar stroke and/or development of acute insufficiency syndromes in thearteries of the vertebrobasilar system

3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who hasundergone reperfusion therapy before participation in this study.

4. The presence of anatomical abnormalities of the cerebral vessels (arteriovenousmalformations, cavernous malformations, aneurysms, atresia of at least one of theextracranial arteries) according to the anamnesis or CT/MRI data.

5. Progression of neurological symptoms of stroke, defined as an increase in the NIHSSscore by 4 points at the second assessment (immediately before randomization) fromthe value obtained at the first assessment (immediately after signing the informedconsent form).

6. Surgery on the carotid arteries less than 1 year before screening.

7. History of stroke less than 1 year before screening.

8. Myocardial infarction less than 6 months before screening.

9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).

10. Pregnancy or lactation.

11. Participation in another trial within 28 days prior to enrollment.

12. Use of prohibited medications.