Résumé
Background Glenzocimab is a humanized fragment of a monoclonal antibody directed against the human platelet glycoprotein VI, which has shown promising features, including thrombus growth inhibition and minimal bleeding risk. The first inpatient study suggested the benefit of glenzocimab with alteplase in subgroups of patients with acute ischemic stroke (AIS) receiving endovascular treatment (EVT), with increased reperfusion rates and decreased risk of symptomatic hemorrhagic transformation. The objective of the GREEN (Glenzocimab for REperfusion in the setting of Endovascular therapy for brain infarctioN) study is to evaluate the efficacy of glenzocimab with EVT compared with EVT plus placebo, with or without intravenous thrombolysis (IVT), on functional outcome.Methods GREEN is a multicenter, randomized, double blind, placebo controlled study. Participants presenting with AIS and a large vessel occlusion of the anterior circulation (intracranial internal carotid artery or middle cerebral artery, or both), with symptoms onset within 24 hours, will be randomized to one of two groups: intravenous glenzocimab 1000 mg with standard of care (SoC-EVT +/- IVT) or SoC (EVT +/- IVT) plus placebo. The main primary efficacy endpoint is functional outcome (assessed by the modified Rankin Scale score) at 90 days.Conclusion This is the first randomized trial evaluating the efficacy of glenzocimab with EVT. This prospective trial aims to determine whether glenzocimab with EVT improves functional outcome.Trial registration ClinicalTrials.gov NCT05559398