2025-521269-28-00招募中2 期
A randomized placebo-controlled double-blind trial phase II two-arm study to investigate infarct growth over 72 hours assessed with diffusion weighted imaging on MRI after treatment with intravenous tocilizumab or placebo in patients above 18 years of age with acute ischemic stroke undergoing endovascular thrombectomy.
Oslo University Hospital HF5 个研究点 分布在 2 个国家目标入组 236 人开始时间: 2026年4月15日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 5
- 主要终点
- ΔDWI lesion volume
研究概览
简要总结
To assess the efficacy of tocilizumab given before/during EVT, on infarct growth in acute ischemic stroke patients at 72 hours after EVT.
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
- 否
入选标准
- •Participant must be above 18 years of age at the time of signing the informed consent.
- •Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines.
- •Onset of stroke symptoms (last-known-well) time to randomization time within 12 hours.
- •Large vessel occlusion in the anterior circulation (terminal internal carotid artery, M1 or M2 segment of MCA. Tandem extracranial carotid and intracranial occlusions are permitted).
- •Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 4 of the protocol.
- •Capable of giving signed informed consent or given by legal representative as described in Appendix I, section 10.1.2., including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Any intracranial haemorrhage during the qualifying imaging.
- •Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial.
- •Contraindications to MRI.
- •Absent or poor collateral circulation during qualifying imaging.
- •Known thrombocytopenia (platelet count <100 × 10³/µL), neutropenia, or elevated liver enzymes (ALT or AST >1.5 × the upper limit of normal [ULN]).
- •Large core of established infarction (ASPECTS 0-2).
- •Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg at baseline, despite appropriate medical management.
- •Known hypersensitivity to tocilizumab or any of the excipients listed in section 6.1 of the SmPC: Sucrose, Polysorbate 80 (E 433), Disodium phosphate dodecahydrate (for pH adjustment), Sodium dihydrogen phosphate dihydrate (for pH adjustment) and water for injections.
- •Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
- •Malignancies, ongoing infection, immunodeficiency, or any suspicion of acute infection.
- •Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic, or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
- •Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure
- •Patients receiving immunosuppressive drugs other than prednisolone ≤ 10 mg/day.
研究组 & 干预措施
RoActemra 20 mg/mL concentrate for solution for infusion
Test
干预措施: RoActemra 20 mg/mL concentrate for solution for infusion (Drug)
Natriumklorid B. Braun 9 mg/ml infusjonsvæske, oppløsning
Placebo
干预措施: Natriumklorid B. Braun 9 mg/ml infusjonsvæske, oppløsning (Drug)
结局指标
主要结局
ΔDWI lesion volume
ΔDWI lesion volume
次要结局
- DWI lesion volume
- ΔFLAIR lesion volume
- FLAIR lesion volume
- Change in levels of brain derived (BD)-Tau
- Change in levels of high-sensitivity C-reactive protein (hsCRP)
- NIHSS
- mRS score
- EQ-5D-5L domains and VAS
- Occurrence of death (all-cause and stroke-related)
- Occurrence of symptomatic intracranial haemorrhage
- Occurrence of any intracranial haemorrhage
- Occurrence of any infection
- Occurrence of pneumonia
- Occurrence of serious adverse events
- Occurrence of adverse events
- Blood levels of circulating surrogate markers
- Blood levels of immune activation -and inflammatory markers
- Alterations in immune cell transcriptomics and genomic alterations in relation to primary and secondary endpoints.
- Serum concentrations of tocilizumab
- Rate of mortality
- Worsening of index stroke defined as (A) progression of infarct core, or haemorrhagic transformation of the index stroke, as documented by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥4-point increase from lowest NIHSS during hospitalization or (B) results in death from the index stroke.
- Occurence of NIHSS score 0-2
- Sex difference in infarct growth, NIHSS, mRS, EQ-5D-5L domains and VAS
- Mean MCA peak systolic velocity ratio
- Median NIHSS
- Median mRS
- Mean score on EQ-5D-5L domains and VAS
- Atrophy, infarct volume at MRI
- Blood levels of immune activation and inflammatory markers
- Rate of major cardiovascular events (MACE)
研究者
Anne Hege Aamodt
Scientific
Oslo University Hospital HF
研究点 (5)
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