The goal of this phase II, placebo-controlled intervention study is to investigate whether tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, may have a neuroprotective effect by reducing infarct growth in adults with acute ischemic stroke.
The main question it aims to answer is:
Does treatment with tocilizumab given before or during endovascular therapy (EVT) reduce infarct growth 72 hours after EVT compared with placebo in adults with acute ischemic stroke?
Researchers will compare tocilizumab with placebo to determine whether infarct growth is smaller in participants receiving tocilizumab.
Participants will:
Receive either a single dose of tocilizumab or placebo before or during EVT. Undergo standard endovascular treatment for acute ischemic stroke. Undergo brain MRI approximately 72 hours after EVT to assess infarct growth. Have clinical assessments and other study-related examinations and follow-up according to the study protocol.
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.
Any intracranial haemorrhage during the qualifying imaging.
Malignancies, immunodeficiency, ongoing infection or any suspicion of acute infection.
Clinical history, prior imaging or clinical judgment suggesting that the intracranial occlusion is chronic, or there is a suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg at baseline, despite appropriate medical management.
Parallel
Tociliuzumab
DrugParticipants randomized to this arm will receive a single intravenous dose of tocilizumab in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Tocilizumab will be administered before or during EVT, according to the study protocol.
Placebo
DrugParticipants randomized to this arm will receive a single intravenous dose of matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Placebo will be administered before or during EVT, according to the study protocol.
Infarct growth on brain MRI (mL)
Infarct growth is defined as the change in DWI lesion volume from baseline to 72 hours after completion of EVT. DWI lesion volume will be measured on brain MRI at baseline and 72 hours after completion of EVT. Infarct growth will be calculated as the DWI lesion volume at 72 hours minus the baseline DWI lesion volume.
Infarct volume on brain MRI at 72 hours after EVT (mL)
DWI lesion volume measured on brain MRI at 72 hours after completion of EVT.
Change in FLAIR lesion volume from baseline to 72 hours after EVT
Change in FLAIR lesion volume from the first post-EVT brain MRI to the brain MRI at 72 hours after EVT. The first post-EVT MRI will be performed within 8 hours after completion of EVT. Change in FLAIR lesion volume will be calculated as lesion volume at 72 hours minus lesion volume on the first post-EVT MRI.
Effect of tocilizumab given before/during EVT on FLAIR lesion volume at 72 hours after EVT in patients with acute ischemic stroke
FLAIR lesion volume measured on brain MRI at 72 hours after completion of EVT
Change in high-sensitivity C-reactive protein (hsCRP) levels
Change in high-sensitivity C-reactive protein (hsCRP) levels from baseline to 72 hours and 90 days after completion of EVT
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Oslo University Hospital
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Collaborator
University Hospital, Akershus
Collaborator
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Odense University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
