Safety Evaluation of 3K3A-APC in Ischemic Stroke

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