Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy

Trial details

Who runs it

Hopital Fondation Adolphe De Rothschild

Trial code

EU 2023-509615-92-00

Record updated

2024. május 22.

Original description

To assess, in AIS patients with baseline large ischemic core eligible for EVT, the efficacy of intravenous infusion of glenzocimab versus placebo on the proportion of good functional outcome at 3 months.Read full original descriptionShow less

To assess, in AIS patients with baseline large ischemic core eligible for EVT, the efficacy of intravenous infusion of glenzocimab versus placebo on the proportion of good functional outcome at 3 months.

Inclusion: Age >18 years old; Acute ischemic stroke due to an isolated proximal anterior large vessel occlusion (M1 and M2 segment of the middle cerebral artery, terminal internal carotid artery (TICA); Indication of EVT within the time window of 0 to 24 hours in participants treated with or without intravenous thrombolysis; Presenting with a baseline infarct core volume assessed on the MRI (DWI sequence) or CT scan with an ASPECTS<6; All women in age of procreating must have a negative serum/urine pregnancy test at baseline; Affiliation to social security or any health insurance; Informed consent signed : By the patient; Or informed consent signed by a family member/ trustworthy person if his condition does not allow him to express his consent by written (L1111-6); In a situation urgently and in absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.

Exclusion: Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion; Patients known to have already received other humanized fragment of monoclonal antibody (risk of anaphylaxis); Patients known to be under ongoing immunosuppressive therapy; Gastrointestinal or urinary tract haemorrhage in previous 21 days; Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L3212-1 and L3123-1 and persons admitted to a health or social institution for purposes other than research (L1121-6); Significant pre-stroke disability (mRS>2); Patients known to be under ongoing anti-cancer treatment (radiotherapy, chemotherapy, immunotherapy); Patient with intracranial haemorrhage; Known hypersensitivity to glenzocimab or to any of the excipients; Known hypersensitivity to the gadolinium used for the brain MRI perfusion, or one of its excipients; Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate < 30mL/Min/1.73m2; Patients receiving anticoagulants within the last 24 hours and: For heparin, an elevated aPTT -greater than upper limit of normal for laboratory; For vitamin K antagonists (ex: warfarin), an INR >1.7; For direct thrombin inhibitors or direct factor Xa inhibitors, a plasmatic dosage of the drug greater than upper limit of normal for laboratory; Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion; Platelet count <100 000 mm3; Possible tandem occlusion on the baseline imaging requiring an eventual stenting; Adults subject to a legal protection measure (L1121-8); Significant mass effect with midline shift as confirmed on CT/MRI; Pregnant or breastfeeding woman.

EU CTIS 2023-509615-92-00