Neurocritical Care Trials

• Age ≥ 45 years.
• Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
• Modified Rankin Scale (MRS) score ≤ 4.
• Ability to be randomized within 3 to 120 days after stroke onset.
• ESUS (embolic stroke of underdetermined source).

• History of atrial fibrillation
• Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
• Need for antiplatelet agent other than aspirin, such as clopidogrel after implantation of a coronary artery stent.
• History of spontaneous intracranial hemorrhage.
• Chronic kidney disease with serum creatinine ≥2.5 mg/dL.

Primary Inclusion Criteria:

• Male or female subjects ≥18 years of age
• Clinical diagnosis of ischemic stroke involving cerebral cortex
• Onset of stroke symptoms must have occurred 18 to 36 hours prior to the planned start of administration of the investigational product
• Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
• A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

Primary Exclusion Criteria:

• Presence of a lacunar or a brainstem infarct
• Comatose state
• Brain hemorrhage
• Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study