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.
Key facts
- Where
- Aalborg, Aarhus N és Copenhagen Oe, DániaSee the 3 sites
- Phase
- 2. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaToborzás még nem indult
- Aarhus UniversitetAarhus N, DániaToborzás még nem indult
- Copenhagen University HospitalCopenhagen Oe, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2025-521269-28-00
- Record updated
- 2026. október 1.
- Original description
To assess the efficacy of tocilizumab given before/during EVT, on infarct growth in acute ischemic stroke patients at 72 hours after EVT.Read full original descriptionShow less
To assess the efficacy of tocilizumab given before/during EVT, on infarct growth in acute ischemic stroke patients at 72 hours after EVT.
Inclusion: 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.
Exclusion: Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial; Any intracranial haemorrhage during the 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]); 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; Contraindications to MRI; Absent or poor collateral circulation during qualifying imaging; 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.