Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke
ConditionIschemic Stroke
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPharmasoft
About this trial
The primary objective of this study is to further define the mechanisms of action of Mexidol® (solution for intravenous and intramuscular injection, 50 mg/ml) and Mexidol® FORTE 250 (film-coated tablets, 250 mg) in the hyperacute and acute periods of ischemic stroke, and to evaluate their impact on clinical and neuroimaging outcomes of the disease.
Eligibility criteria
Qualifiers
Signed and dated Informed Consent Form (ICF) by the patient or their legal representative (in case of physical inability to sign), and/or a Decision of the Medical Board.
Men and women aged 18 to 90 years (inclusive) at the time of signing the ICF or Decision of the Medical Board.
First-ever hemispheric ischemic stroke (ICD-10 codes: I63.0-I63.9), confirmed by neuroimaging (CT or MRI).
Presence of occlusion in the internal carotid artery (ICA) system at any level, including the middle cerebral artery (MCA) and anterior cerebral artery (ACA) (anterior circulation) and/or presence of neuroimaging signs, characteristic of acute cerebral ischemia (based on CT perfusion and/or MRI data in accordance with current Clinical Guidelines). Note: Presence of internal carotid artery (ICA) occlusion is not a mandatory criterion; neuroimaging signs of acute cerebral ischemia (CT perfusion/MRI) are sufficient for inclusion.
Disqualifiers
Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product.
Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Inability to take oral medications.
Contraindications or inability to undergo CT/MRI procedures (including, but not limited to: permanent cardiac pacemakers/neurostimulators; inner ear prosthesis, ferromagnetic or electronic middle ear implants, hemostatic clips, cardiac valve prostheses, or any other metal-containing structures; ferromagnetic fragments; insulin pumps; severe claustrophobia).
Trial design
Treatments tested in this trial
- Mexidol
- Glycine
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov