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
- Conditions
- 10029305Acute ischemic stroke (AIS)Stroke
- Registration Number
- NL-OMON54395
- Lead Sponsor
- oNO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 45
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)
a. NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral
artery (MCA) occlusion or
b. 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
1) Treatment 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) 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Reducing global disability in participants with acute ischemic stroke (AIS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to determine the efficacy of nerinetide in:<br /><br>• Reducing mortality rate<br /><br>• Improving activities of daily living<br /><br>• Improving health related quality of life</p><br>