RecruitingPhase 3NCT07167550
The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients
Sponsor
Tatchempharmpreparaty, JSC
Enrollment
184 participants
Start Date
Sep 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
Eligibility
Min Age: 35 YearsMax Age: 80 Years
Inclusion Criteria7
- Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
- Age 35-80.
- Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.
- Verified by CT/MRI current hemispheric ischemic stroke.
- NIHSS score ≥5 and ≤15 at screening.
- Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
- Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.
Exclusion Criteria12
- Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
- Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
- A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
- The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT/MRI data.
- Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).
- Surgery on the carotid arteries less than 1 year before screening.
- History of stroke less than 1 year before screening.
- Myocardial infarction less than 6 months before screening.
- Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
- Pregnancy or lactation.
- Participation in another trial within 28 days prior to enrollment.
- Use of prohibited medications.
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Interventions
DRUGDimephosphon®
1 g/ml, concentrate for solution for intravenous infusion
DRUGPlacebo
Placebo IV solution
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07167550
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