Status:
COMPLETED
Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
Lead Sponsor:
NoNO Inc.
Collaborating Sponsors:
University of Calgary
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use ...
Detailed Description
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose with a single interim analysis. Because AIS (acute ischemic stroke) is a medical emergency, t...
Eligibility Criteria
Inclusion
- Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
- Age 18 years or greater.
- Onset (last-known-well) time to randomization time within 12 hours.
- Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS):
- NIHSS \> 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion; or
- NIHSS \> 10 for M2-MCA occlusion.
- Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) ≥ 95. Patient must be living without requiring nursing care.
- Qualifying imaging performed less than 2 hours prior to randomization.
- Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
Exclusion
- Treated with a tissue plasminogen activator (e.g., alteplase or tenecteplase) within 24 hours before randomization.
- Determination by the treating physician, based on current treatment guidelines and medical evidence, that treatment with a plasminogen activator is indicated.
- Large core of established infarction defined as ASPECTS 0-4.
- Absent or poor collateral circulation on qualifying imaging (e.g. collateral score of 0 or 1).
- Any intracranial hemorrhage on the qualifying imaging.
- Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
- Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure.
- Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
- Estimated or known weight \> 120 kg (264 lbs).
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
- Known prior receipt of nerinetide for any reason, including prior enrolment in this ESCAPE-NEXT trial.
- Severe known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
- Severe or fatal comorbid illness that will prevent improvement or follow up.
- Inability to complete follow-up treatment to Day 90.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion.
Key Trial Info
Start Date :
December 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT04462536
Start Date
December 6 2020
End Date
August 31 2023
Last Update
June 22 2025
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