Safety Evaluation of 3K3A-APC in Ischemic Stroke

Inclusion Criteria: * Acute ischemic stroke * Able to receive IV tPA, mechanical thrombectomy or both * National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5 * Signed informed consent * Mechanical thrombectomy subjects only: onset time to arterial puncture time \< 6 hours Exclusion Criteria: * History of stroke or penetrating head injury within 90 days prior to enrollment * History of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy * Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm requiring intervention during the acute study period * Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period * Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2 * Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large core occlusion as defined by local protocol * Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT) * Severe hypertension or hypotension * Glomerular filtration rate (GFR) \<35 mL/min * Blood glucose concentration \< 50 mg/dL * Prior exposure to any exogenous form of APC