Neuroprotection in Acute Cerebral Ischemia II

Inclusion criteria

• Age ≥ 18 years
• Diagnosis of ischemic stroke in the middle cerebral artery territory, confirmed by clinical evaluation by a neurologist. Baseline CT scan and follow-up CT/MRI at 12-36 hours are required
• Patients with a diagnosis of acute ischemic stroke, with symptom onset within 48 hours prior to clinical evaluation. In cases of unwitnessed onset, the time of onset is defined as the last time the patient was seen well ("last seen well")
• NIHSS score ≥ 6 at randomization (after any reperfusion treatment, if applicable)
• Written informed consent signed by the patient or legal representative.

Exclusion criteria

• Previous ischemic or hemorrhagic stroke with residual mRS > 1
• Pre-stroke modified Rankin Scale (mRS) > 1
• Other severe or complex conditions that may confound the evaluation of the treatment
• Pregnant or breastfeeding women, or women with a positive or indeterminate pregnancy test; women of childbearing potential who cannot exclude the possibility of pregnancy
• Diagnosis of lacunar syndrome
• History of epilepsy or occurrence of seizures in the acute post-stroke phase
• Ongoing treatment with anti-glutamatergic drugs: memantine, ketamine, and lamotrigine
• Undergoing decompressive craniectomy
• Current participation in other interventional clinical studies
• Presence of symptomatic intracranial hemorrhage. For asymptomatic hemorrhagic transformations, the SITS-MOST classification will be used:

HI 1: small petechiae along the margins of the infarct HI 2: more confluent petechiae within the infarct area without space-occupying effect PH 1: blood clot(s) not exceeding 30% of the infarct area with mild space-occupying effect PH 2: blood clots exceeding 30% of the infarct area with significant space-occupying effect PHr 1: small or medium-sized blood clots located remote from the infarct, possibly with mild space-occupying effect PHr 2: large confluent dense blood clots remote from the infarct, with significant space-occupying effect.

Only patients classified as HI1 and HI2 may be enrolled, at the investigator's discretion. Patients classified as PH1, PH2, PHr1, or PHr2 will be excluded from the study.