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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mexidol
DrugPhase 1 (Days 1-10): Mexidol® solution, 500 mg (10 ml) twice daily (total daily dose 1000 mg) administered via IV infusion in 100-200 ml of 0.9% NaCl solution for 10 days. Infusion rate: 40-60 drops per minute. Phase 2 (Days 11-70): Mexidol® FORTE 250 film-coated tablets, 250 mg three times daily (total daily dose 750 mg) for 60 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.
Glycine
DrugGlycine, 100 mg sublingual tablets, 1 g (10 tablets) daily for 5 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Mexidol GroupExperimental treatment 1 intervention
Group B: Glycine GroupActive comparator 1 intervention
Group C: Healthy VolunteersNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Infarct Volume at Visit 2 (Day 11)
Evaluation of the ischemic lesion volume using Diffusion-Weighted Imaging (DWI).
Time frame
Day 11 (Visit 2).Secondary outcomes
1
Change in Infarct Volume from Baseline to Visit 2 (Day 11)
Assessment of ischemic lesion dynamics measured by Diffusion-Weighted Imaging (DWI).
Time frame
Baseline (Visit 0) and Day 11 (Visit 2)2
Incidence of Symptomatic Hemorrhagic Transformation (sHT) by Visit 2 (Day 11)
Number of participants with new intracranial hemorrhage associated with any of the following, according to the Heidelberg Criteria: * Increase in NIHSS total score by ≥ 4 compared to the score immediately prior to deterioration; OR * Increase in any single NIHSS subscale score by ≥ 2; OR * Need for intubation, hemicraniectomy, or ventricular drainage; OR * No other clinical explanation for the patient's deterioration.
Time frame
Up to Day 11 (Visit 2)3
Change in laboratory biomarkers (TNF-α, BDNF, NSE, GFAP, MMP-9, Caspase-3, VCAM-1, MBP, fibronectin)
Evaluation of the dynamics of laboratory markers to clarify the mechanism of action.
Time frame
Baseline (Visit 0) and Day 11 (Visit 2)4
Assessment of coagulation parameters (D-dimer, fibrinogen).
Evaluation of blood coagulation dynamics
Time frame
Baseline (Visit 0) and Day 11 (Visit 2) Source ClinicalTrials.gov