2023-509615-92-00招募中2 期
Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy
Hopital Fondation Adolphe De Rothschild14 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2024年5月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 14
- 主要终点
- Functional outcome at 3 months will be assessed with the modified Rankin Scale (mRS) score dichotomized 0 to 3 versus 4 to 6, collected by phone by trained professionals blinded to the treatment allocation.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Functional outcome at 3 months will be assessed with the modified Rankin Scale (mRS) score dichotomized 0 to 3 versus 4 to 6, collected by phone by trained professionals blinded to the treatment allocation.
Functional outcome at 3 months will be assessed with the modified Rankin Scale (mRS) score dichotomized 0 to 3 versus 4 to 6, collected by phone by trained professionals blinded to the treatment allocation.
次要结局
- Proportion of patients with No-reflow (NR) phenomenon on post EVT perfusion imaging (visually demonstrable persistent hypoperfusion on rCBV or rCBF within the infarct lesion on qualitative maps processed according to validated software)
- Proportion of patients with symptomatic intracranial hemorrhage assessed according to the Heidelberg classification, on a brain CT scan performed between 24-36 hours after EVT
- Proportion of patients with any intracranial hemorrhage assessed according to the Heidelberg classification on a brain CT scan performed between 24-36 hours after EVT
- All-cause death rate at 3 months
- The distribution of mRS score at 3 months (Annex 1)
- Proportion of patients with favorable functional outcome defined by a modified Rankin Scale score 0-2 at 3 months
- Score of the MoCA 5-minutes at 3 months
- Incidence of complete recanalization defined by a mTICI score of 2c or 3 on the post-EVT cerebral angiography
- Incidence of successful recanalization defined by a mTICI score of 2b, 2c or 3 on the post-EVT cerebral angiography
- Proportion of patients with decompressive hemicraniectomy surgery
- Proportion of patients with neurological improvement defined by a decrease in NIHSS score > 8 points between the baseline score and the score at 24-36h after EVT
- Cerebral infarct volume growth between baseline and 24h brain MRI
- The number of EVT passes
- Time (in minutes) between the arterial puncture and recanalization occurrence
- Incidence of Serious/Non-Serious Adverse Events including bleeding-related events.
- Cost per additional patient with a mRS 0-3 with glenzocimab use and cost per QALY (Quality adjusted Life Year) gained at 12 months.
- Proportion of patients with favorable functional outcome defined by a modified Rankin Scale score 0-2 at 12 months
- Score of the MoCA 5-minutes at 12 months
研究者
Jean-Philippe Desilles
Scientific
Hopital Fondation Adolphe De Rothschild
研究点 (14)
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