Ischemic Stroke Clinical Trial
— IRISOfficial title:
Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment: a Double-blind, Randomized, Placebo-controlled Trial
Tocilizumab may exert neuroprotective effects in patients with ischemic stroke undergoing endovascular treatment
Status | Recruiting |
Enrollment | 108 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | - Inclusion criteria: 1. Age 18-80 years. 2. Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1, or M2 segment. 3. NIHSS = 6. 4. Meeting the criteria of endovascular treatment: ? ASPECTS score = 6, possibile to start endovascular treatment within 6 hours from stroke onset. ? Stroke onset between 6-16 hours, meeting DEFUSE-3 criteria (infarct core volume < 70ml, mismatch ratio = 1.8, and mismatch volume > 15ml), or DAWN criteria (NIHSS = 10 and infarct core volume < 31ml; or NIHSS = 20 and infarct volume 31-51ml). ? Stroke onset between 16-24 hours, meeting DAWN criteria (NIHSS = 10 and infarct core volume < 31ml; or NIHSS = 20 and infarct volume 31-51ml). ? When ASPECTS score is < 6, meeting RESCUE-Japan LIMIT criteria (ASPECTS score 3-5; stroke onset within 6 hours or between 6-24 hours but no acute stroke signs on FLAIR), or ANGEL-ASPECT criteria (stroke onset within 24 hours, ASPECTS 3-5; or onset within 24 hours, ASPECTS 0-2 and infarct core volume 70-100 mL; or onset between 6-24 hours, ASPECTS > 5 and infarct core volume 70-100 mL), or SELECT2 criteria (ASPECTS 3-5; or infarct core volume greater than 50ml). 5. Experimental drug administration had to be possible within 24 hours after stroke onset. 6. Obtained Informed consent from the patient or their legal representative. - Exclusion Criteria: 1. Hemorrhagic diseases visible on head CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc. 2. Pre-stroke 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, thrombocytopenic diseases, etc. 7. Systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg despite blood pressure control. 8. Neutrophil < 2×10 9/L. 9. Platelet < 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 greater than 1.5 times the upper limit of normal. 12. Known recent or current serum creatinine exceeding 1.5 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 an 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. |
Country | Name | City | State |
---|---|---|---|
China | Suzhou Municipal Hospital of Anhui Province | Suzhou | Anhui |
Lead Sponsor | Collaborator |
---|---|
Suzhou Municipal Hospital of Anhui Province | Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of hsCRP levels from admission to 72 hours | 72 hours | ||
Other | Change of inflammatory blood biomarkers | Interleukin-6 | baseline, 24 hours, 48 hours, and 72 hours | |
Primary | Change from baseline in infarct-core volume | The infarct-core volume is determined by diffusion-weighted MRI, CT, or CTP images. | 72 hours | |
Secondary | Early neurological improvement | Decrease in National Institute of Health stroke scale (NIHSS) score of =8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit | within 24 hours | |
Secondary | NIHSS score | National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit | 24 hours | |
Secondary | Proportion of successful reperfusion (mTICI 2b/3) | mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow) | immediate postoperative | |
Secondary | Proportion of recanalization on follow-up CTA or MRA | 72 hours | ||
Secondary | Incidence of cerebral hemorrhage | 72 hours | ||
Secondary | Incidence of symptomatic cerebral hemorrhage | 72 hours | ||
Secondary | NIHSS score | National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit | 7 days | |
Secondary | Incidence of stroke-associated pneumonia | 7 days | ||
Secondary | Incidence of decompressive craniectomy | 7 days | ||
Secondary | Proportion of patients with functional independence (mRS 0-2) | Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability | 90 days | |
Secondary | Shift analysis of mRS score | Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability | 90 days | |
Secondary | Barthel Index | The Barthel index is an ordinal scale for measuring performance of activities of daily living. Scores ranges from 0 to 20, with 0 indicating severe disability and 19 or 20 indicating no disability that interferes with daily activities. | 90 days | |
Secondary | EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) | EQ-5D is a standardized instrument for the measurement of health status. Scores range from -0.33 to 1.00, with higher scores indicating a better quality of life | 90 days | |
Secondary | Death | 90 days | ||
Secondary | Adverse events and serious adverse events | 90 days |
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