GREEN A randomized, double-blind, multi-center, placebo-controlled, efficacity and safety study of glenzocimab used as an add-on therapy on top of mechanical thrombectomy for acute ischemic stroke

Acute ischemic stroke

The primary efficacy endpoint is the functional outcome at day 90 assessed by the modified mRS at day 90 +/- 15 days.

Efficacy : • Favourable functional outcome defined by a mRS score ≤ 2 at day 90 • Proportion of patient with severe handicap (mRS 4-6) at Day 90 • Overall Survival at day-90 and 1 year • Early reperfusion outcomes: o Stroke volume by brain imaging at 24 hrs o Reperfusion at the end of MT procedure assessed by eTICI score o Early neurological improvement by NIHSS at 24 hrs • EQ-5D-5L at day 90 and 1 year, Safety: • Incidence of symptomatic or non-symptomatic ICH at 24 hrs • Incidence of symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs • Incidence of non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs • Incidence, nature and severity of Adverse Events, SAEs, SUSARs, Bleeding-Related Events (BREs) and Treatment-Emergent Adverse Events (TEAEs), at 24 hrs, at D7/discharge, 30 days and 90 days • Incidence of bleeding-related events at 90 days • Anti-glenzocimab, Cost -effectiveness • Cost per QALY (Quality adjusted Life Year) gained with the use of glenzocimab in addition to EVT • Cost per patient with a mRS score ≤ 2 gained with the use of glenzocimab in addition to EVT

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