Ischemic Stroke
Conditions
Keywords
large vessel occlusion, endovascular treatment, posterior circulation, interleukin-6 inhibitor, neuroprotection
Brief summary
This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.
Detailed description
This is an investigator-initiated, prospective, multicenter phase III clinical trial. This trial aims to investigate whether tocilizumab could further improve prognosis for patients with acute posterior circulation large-vessel occlusion stroke receiving endovascular therapy.
Interventions
DRUGTocilizumab
240 mg of tocilizumab injection will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.
DRUGPlacebo
An equivalent volume of placebo will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older, of either sex; 2. Acute ischemic stroke caused by occlusion of the basilar artery; 3. Decide to undergo emergency endovascular treatment; 4. Time from stroke onset to groin puncture within 24 hours; 5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10; 6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6; 7. Signed informed consent from the patients or the legally authorized representatives.
Exclusion criteria
1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage; 2. Pre-stroke modified Rankin scale (mRS) score \>1; 3. Known allergy to tocilizumab or excipients; 4. Known allergy to iodinated contrast agents; 5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity; 6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases; 7. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control; 8. Neutrophils \< 2 × 10\^9 /L; 9. Platelets \< 100 × 10\^9 /L; 10. Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL); 11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal; 12. Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min; 13. Pregnant, lactating, or planning pregnancy within 90 days; 14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia; 15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days; 16. Presence of autoimmune diseases or use of immunosuppressive drugs; 17. Systemic infectious diseases; 18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study; 19. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated; 20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days. | 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS score distribution | 90 days and 1 year | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
| Early neurological improvement at 24 hours | 24 hours | Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2 |
| NIHSS score at 7 days or at early discharge | 7 days | The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes |
| Proportion of patients with mRS score 0-1 | 90 days and 1 year | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
| Proportion of patients with mRS score 0-2 | 90 days and 1 year | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
| Proportion of patients with mRS score 0-4 | 90 days and 1 year | The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
| EQ-5D-5L | 90 days and 1 year | The EQ-5D-5L comprises the same five dimensions: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. |
| Proportion of Barthel Index (BI) 95-100 | 90 days and 1 year | — |
Countries
China
Contacts
CONTACTXunming Ji
CONTACTChuanjie Wu
Outcome results
None listed