Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

Completed · Phase 3 · Has a placebo group

Conditions studied: Stroke, Acute

In brief

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 of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).

Key facts

Study ID

NCT04462536

Run by

NoNO Inc.

People needed

850

Starts

2020-12-06

Expected to finish

2023-08-31

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Providence Little Company of Mary Medical Center - Torrance — Torrance, California, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• University of Miami, Jackson Memorial Hospital — Miami, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• NYU Langone Hospital Brooklyn — Brooklyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Ohio State University, Wexner Medical Center Neurological Surgery — Columbus, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• UPMC Stroke Institute — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Valley Baptist Medical Center - Harlingen — Harlingen, Texas, United States
• Swedish Medical Center - Cherry Hill Campus — Seattle, Washington, United States
• Royal Adelaide Hospital — Adelaide, Australia
• Princess Alexandra Hospital — Brisbane, Australia
• Monash Medical Centre — Clayton, Australia
• Gold Coast University Hospital — Gold Coast, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• John Hunter Hospital — Newcastle, Australia
• Royal Melbourne Hospital — Parkville, Australia
• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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