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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.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521269-28-00
Enrollment
156
Registered
2026-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Brief summary

ΔDWI lesion volume

Detailed description

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, 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, Rate of mortality, 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)

Interventions

DRUGoppløsning
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ΔDWI lesion volume

Secondary

MeasureTime frame
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, 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

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 13, 2026