Project 452339
A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis (ESCAPE-NEXT Trial)
A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis (ESCAPE-NEXT Trial)
Project Information
| Study Type: | Unclear |
| Research Theme: | Clinical |
Institution & Funding
| Principal Investigator(s): | Hill, Michael D; Goyal, Mayank |
| Co-Investigator(s): | Coutts, Shelagh B; Demchuk, Andrew M; Menon, Bijoy K |
| Institution: | University of Calgary |
| CIHR Institute: | Circulatory and Respiratory Health |
| Program: | |
| Peer Review Committee: | Randomized Controlled Trials |
| Competition Year: | 2021 |
| Term: | 2 yrs 6 mths |
Abstract Summary
Stroke remains a major health problem in Canada and globally as the second leading cause of death (globally) and the major cause of adult neurological disability. The ESCAPE-NEXT trial will build upon advances in stroke treatment over the last 25 years. Nerinetide (NA-1) is a Canadian invention developed in Toronto. The ESCAPE trial was a Canadian led trial establishing the role of non-invasive surgery (EVT) for stroke. We conducted the first trial of nerinetide in acute stroke - the ESCAPE-NA1 trial, funded by CIHR - and have shown the first signs of efficacy. We now propose to conduct a second trial to prove the efficacy of nerinetide. The trial will be orchestrated from Calgary and will involve up to 85 centres in North America, Europe and Australasia. Patients with acute ischemic stroke due to a proven large artery blockage will undergo EVT (endovascular thrombectomy - a minimally invasive surgery) to remove the blockage AND will be randomized to receive nerinetide or placebo. All patients will be followed for 3 months to determine their outcome - whether they are able to live at home independently, and again at 1 year to assess their long term outcome. The study will be a major evolution of work in ischemic stroke in Canada and we believe, lead to the first new medical treatment for stroke in 25 years.
No special research characteristics identified
This project does not include any of the advanced research characteristics tracked in our database.