CTIS2023-509615-92-00进行中（未招募）1 期
Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy
Hopital Fondation Adolphe De Rothschild0 个研究点目标入组 304 人开始时间: 2024年2月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Possible tandem occlusion on the baseline imaging requiring an eventual stenting, Adults subject to a legal protection measure (L1121-8), 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)., Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion, 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, Significant pre-stroke disability (mRS>2), Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion, Patients known to have already received other humanized fragment of monoclonal antibody (risk of anaphylaxis), Patients known to be under ongoing anti-cancer treatment (radiotherapy, chemotherapy, immunotherapy), Patients known to be under ongoing immunosuppressive therapy, Significant mass effect with midline shift as confirmed on CT/MRI, Gastrointestinal or urinary tract haemorrhage in previous 21 days, Patient with intracranial haemorrhage, Platelet count <100 000 mm3, 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, Pregnant or breastfeeding woman
研究者
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