Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke

Inclusion Criteria:

1. Acute ischemic stroke (AIS) for immediate endovascular treatment
2. Age 18 or greater.
3. Onset (last-seen-well) time to randomization time within 12 hours.
4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) > 5 at the time of randomization.
5. Pre-stroke (24 hours prior to stroke onset) independent functional status inactivities of daily living with modified Barthel Index (BI) > 90 (95 or 100). Patientmust be living in their own home, apartment or seniors lodge where no nursing care isrequired.
6. Confirmed symptomatic intracranial occlusion, based on multiphase or dynamiccomputerized tomographic angiography (CTA), at one or more of the following locations:Intracranial carotid T/L, M1 middle cerebral artery (MCA). Functionally, when definingthe M1 or the M2, the bulk of the MCA territory must be ischemic.
7. Non-contrast computed tomography (NCCT) and CTA (multiphase or dynamic) for trialeligibility performed or repeated at ESCAPE-NA1 stroke centre with endovascular suiteon-site.
8. Endovascular treatment with declared first endovascular approach as either stentretriever or aspiration device, and intended to be initiated (arterial access) within 60 minutes of baseline/qualifying NCCT and to first recanalization of 90 minutes.Study drug intended to be administered within 60 minutes of the baseline/qualifyingNCCT.
9. Signed informed consent from subject or legally authorized representative or, ifrequired to enable inclusion by applicable national laws and regulations and theapplicable independent review boards/Ethics Committee requirements for obtainingconsent, from the investigator after consultation with an independent physician who isnot otherwise participating in the trial.

Exclusion Criteria:

1. Evidence of a large core of established infarction defined as ASPECTS 0-4.
2. Evidence of absence of collateral circulation on CTA (Collateral score of 0 or 1).
3. Intent to use any endovascular device other than a stent retriever or clot aspirationdevice or intra-arterial medications as the initial thrombectomy approach.
4. Intent to use any intravenous thrombolytic other than alteplase if intravenousthrombolysis is planned.
5. No femoral pulses, very difficult endovascular access or extreme tortuosity of greatvessels that is predicted to result in an inability to deliver timely endovasculartherapy. Direct common carotid or radial/brachial/axillary access is permissible.
6. Estimated or known weight > 120 kg or < 45 kg.
7. Pregnancy; if a woman is of childbearing potential a urine or serum beta humanchorionic gonadotropin (β-hCG) test is positive, or breastfeeding.
8. Severe contrast allergy or absolute contraindication to iodinated contrast preventingendovascular intervention, including any contraindications listed in the prescribinginformation approved by local authorities (e.g., patients with decompensated heartfailure as a contraindication for the use of VISIPAQUE™ 270 in Germany).
9. Clinical history, past imaging or clinical judgment suggests that the intracranialocclusion is chronic or there is suspected intracranial dissection such that there isa predicted lack of success with endovascular intervention.
10. Prior enrolment in the ESCAPE-NA1 trial or prior receipt of NA-1 for any reason.
11. Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) orif known a creatinine clearance < 29 mL/min.
12. Patient has a severe or fatal comorbid illness that will prevent improvement orfollow-up.
13. Patient cannot complete follow-up treatment due to co-morbid non-fatal illness or theyare known to be a visitor to the city or any other known reason for which follow-upwould be impossible (e.g. incarcerated in a federal prison).
14. Participation in another clinical trial investigating a drug, medical device, or amedical procedure in the 30 days preceding study inclusion.