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NCT07509645
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
Conditions: Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 348
Sponsor: Capital Medical University
Location: Suzhou Municipal Hospital Suzhou Anhui
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.
Eligibility Criteria
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 \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) \
Source: ClinicalTrials.gov (NCT07509645). StuddyBuddy aggregates publicly available trial information.