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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.
EU CTIS ID: 2025-521269-28-00
What this study is testing
To assess the efficacy of tocilizumab given before/during EVT, on infarct growth in acute ischemic stroke patients at 72 hours after EVT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- 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.
- 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.
- 5. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.