Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

Exclusion Criteria

• •Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
• •Poor/no collateral circulation in the opinion of the investigator (e.g., collateral score of 0 or 1 if data available).
• •ASPECT score of 0-4.
• •Current AIS is being treated with IV thrombolytic therapy (e.g., alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
• •Intent to use any endovascular device that is not Food and Drug Administration (FDA)-approved.
• •Planned use of intra arterial thrombolytic therapy.
• •Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
• •Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
• •Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g., aortic dissection, carotid stent).
• •Subjects with end stage kidney disease.
• •Part A Cohort 1: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded. Chronic use of anti-platelet drugs is acceptable.
• •Part A Cohort 2: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. Chronic use of anti-platelet drugs is acceptable.
• •Part A Cohort 3 and Part B: With SRC approval, subjects in Part A Cohort 3 and Part B taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization.
• •(If the SRC does not approve expansion of this criterion, then subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded, as in Cohort 1. Chronic use of anti-platelet drugs is acceptable in either case.)
• •Known metastatic malignancy with poor prognosis.
• •Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator. Examples of excluded comorbid conditions include respiratory failure because of pneumonia, chronic diseases with significant disability, or non-ambulatory status. Contact medical monitor for consultation if necessary.
• •Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
• •Subject was a participant in either SCP CL 0001 or SCP CL 0002 and received scp776, or previously participated in SCP-CL-0003.
• •Subject is experiencing moderate or severe hypotension as defined by CTCAE criteria (i.e., symptomatic and requiring medical intervention with fluid resuscitation and/or vasopressors) or a confirmed systolic blood pressure less than 90 mmHg.