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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine if a single dose of nerinetide can reduce neurological 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NoNO Inc.
• Collaborator: University of Calgary

Criteria

Inclusion Criteria:

1. Acute ischemic stroke (AIS) selected for emergency endovascular treatment.

2. Age 18 years or greater.

3. Onset (last-known-well) time to randomization time within 12 hours.

4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS):

1. NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion; or

2. NIHSS > 10 for M2-MCA occlusion.

5. 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.

6. 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.

7. Qualifying imaging performed less than 2 hours prior to randomization.

8. Consent process completed as per national laws and regulation and the applicable ethics committee requirements.

Exclusion Criteria:

1. Treated with an intravenous or intra-arterial 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. Evidence of a large core of established infarction defined as ASPECTS 0-4.

4. Evidence of absence of collateral circulation on qualifying imaging (collateral score of 0 or 1).

5. Any evidence of 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 as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure.

8. 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.

9. Estimated or known weight > 120 kg (264 lbs).

10. Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.

11. Known prior receipt of nerinetide for any reason, including prior enrolment in this ESCAPE-NEXT trial.

12. Severe known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).

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.