IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.
Male or non-pregnant women with acute stroke symptoms aged over 18 years.
Patients having an ischemic stroke or a TIA prior to randomization (Patients having an acute ischemic stroke within 72 hours with NIHSS score≤5 at baseline, or patients having a TIA within 72 hours with Oxfordshire Community Stroke Project on the basis of age, blood pressure, clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline).
The entry event is attributed to symptomatic atherosclerosis (50-99%) in an intracranial qualifying artery (intracranial carotid artery (C4-7), middle cerebral artery (M1), intracranial vertebral artery or basilar artery) confirmed by CT, MR angiography, or digital subtraction angiography.
Informed consent obtained from patients or their legal representatives.
Thrombolytic therapy or thrombectomy within 24 hours prior to enrollment.
Pre-stroke mRS score ≥ 2.
Combined or previous intracranial hemorrhage: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
Any of the following unequivocal cardiac source of embolism: chronic or paroxysmal atrial fibrillation, sinus node dysfunction, mitral stenosis, prosthetic heart valves, endocarditis, left ventricular mural thrombus or valvular vegetation, myocardial infarction within three months, dilated cardiomyopathy, spontaneous echogenic defects in the left atrium or an ejection fraction of less than 30%.
Zhujiang Hospital
Lead sponsor
Shenzhen Second People's Hospital
Collaborator
Central People's Hospital of Zhanjiang
Collaborator
Shantou Central Hospital
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
Guangzhou First People's Hospital
Collaborator
Peking University Shenzhen Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator