A Multicentre, Randomised, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy
Lead PI: Prof Bruce Campbell
Status: Closed
No. of Patients Currently Recruited: No. of Patients Required: 1120
ESCAPE-NA1 is examining the rapid addition of single dose NA-1 to the treatment of acute ischemic stroke patients with large vessel occlusion undergoing endovascular thrombectomy. NA1 is a small protein designed to protect brain cells from the effects of stoke. NA1 works by reducing the damage induced by the lack of blood or caused in the process of restoring the blood flow. Patients are randomized 1:1 to study drug (active drug or saline placebo) and then followed for 90 days. NA is shown to be safe and reduce brain injury during aneurysm treatment. The primary outcome is disability measured on the modified Rankin Scale at 90 days. Up to 1120 patients will be recruited globally from 50 centres in Canada, US, Europe/UK, South Korea and Australia.
Trial URL:
https://protect-au.mimecast.com/s/jzm_CoVzwKhx144xt5-0sp?domain=clinicaltrials.gov
https://www.ucalgary.ca/dcns/research/escape-na1/escape-na1-synopsis