Mikaël Mazighi, Jerome Lambert, Benjamin Gory, Pierre Seners, Lionel Calvière, Tae Hee Cho, Agnès Aghetti, Marco Pasi, Gregoire Boulouis, Bertrand Lapergue, Arturo Consoli, Guillaume Turc, Aymeric Rouchaud, Valerie Wolff, Raoul Pop, Laurent Suissa, Sébastien Richard, Charlotte Cordonnier, Caroline Arquizan, Vincent Costalat, Alexis Guedon, Christophe Cognard, Lakhdar Mameri, Simon Escalard, Hocine Redjem, Stanislas Smajda, Erwan Robichon, Amira Al Raaisi, William Boisseau, Raphaël Blanc, Benjamin Maier, Perrine Boursin, Estelle Dubus, Jean-Philippe Desilles, Michel Piotin, Matthieu Resche Rigon, Jean-Marc Olivot
{"title":"Glenzocimab for reperfusion in the setting of endovascular therapy for brain infarction: GREEN study.","authors":"Mikaël Mazighi, Jerome Lambert, Benjamin Gory, Pierre Seners, Lionel Calvière, Tae Hee Cho, Agnès Aghetti, Marco Pasi, Gregoire Boulouis, Bertrand Lapergue, Arturo Consoli, Guillaume Turc, Aymeric Rouchaud, Valerie Wolff, Raoul Pop, Laurent Suissa, Sébastien Richard, Charlotte Cordonnier, Caroline Arquizan, Vincent Costalat, Alexis Guedon, Christophe Cognard, Lakhdar Mameri, Simon Escalard, Hocine Redjem, Stanislas Smajda, Erwan Robichon, Amira Al Raaisi, William Boisseau, Raphaël Blanc, Benjamin Maier, Perrine Boursin, Estelle Dubus, Jean-Philippe Desilles, Michel Piotin, Matthieu Resche Rigon, Jean-Marc Olivot","doi":"10.1136/jnis-2025-023606","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05559398.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of NeuroInterventional Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/jnis-2025-023606","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NEUROIMAGING","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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