A Multicentre Randomized Double-blinded Placebo-controlled Parallel Group Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Stroke
  • Age: Between 18 - 105 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Acute ischemic stroke (AIS) selected for emergency endovascular treatment
    2. Onset (last-known-well) time to randomization time within 12 hours
    3. Disabling stroke
    4. Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA
    5. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) = 95
    6. Qualifying imaging performed less than 2 hours prior to randomization
    7. Provide written informed consent form

You may not be eligible for this study if the following are true:

    1. Treated with a tissue plasminogen activator (e.g., alteplase or tenecteplase) within 24 hours before randomization
    2. Determination by the treating physician, based on current treatment guidelines and medical evidence, that treatment with a plasminogen activator is indicated
    3. Large core of established infarction defined as ASPECTS 0-4
    4. Absent or poor collateral circulation on qualifying imaging
    5. Any intracranial hemorrhage on the qualifying imaging
    6. Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority
    7. Endovascular thrombectomy procedure is completed
    8. Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection
    9. Estimated or known weight > 120 kg (264 lbs)
    10. Pregnancy/Lactation
    11. Known prior receipt of nerinetide for any reason
    12. Severe known renal impairment
    13. Severe or fatal comorbid illness that will prevent improvement or follow up
    14. Inability to complete follow-up treatment to Day 90
    15. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion



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