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%.
Parallel
Tocilizumab
DrugSingle dose intravenous application
NaCl 0.9% 100ml
DrugSingle dose intravenous application
The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days
Stroke is defined as an acute episode of focal neurological dysfunction associated with cerebral vascular injury, with no apparent non-vascular cause such as brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease. Ischemic stroke is defined as an acute episode of a new focal neurological deficit lasting \>24 hours, an increase in existing focal neurological deficit lasting \>24 hours, or a focal neurological deficit lasting \<24 hours that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is not attributable to a non-ischemic etiology. Hemorrhage may be a consequence of ischemic stroke, and in this situation, the stroke is an ischemic stroke with hemorrhagic transformation but not a hemorrhagic stroke.
The functional neurological status at 6(±1) days or discharge if earlier from baseline
The functional neurological status is evaluated through National Institute of Health Stroke Scale(NIHSS). The NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating more severe disability. The scale includes measures of level of consciousness, extra ocular movements, motor and sensory tests, coordination, language and speech evaluations.
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 30(±3) days
IS is defined as an acute episode of a new focal neurological deficit lasting \>24 hrs, an increase in existing focal neurological deficit lasting \>24 hrs, or a focal neurological deficit lasting \<24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS. Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS. MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia. TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 90(±7) days
IS is defined as an acute episode of a new focal neurological deficit lasting \>24 hrs, an increase in existing focal neurological deficit lasting \>24 hrs, or a focal neurological deficit lasting \<24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS. Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS. MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia. TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
Proportion of patients with functional independence at 90(±7) days
Functional independence is defined as the modified Rankin Scale(mRS) score ranging from 0-2. The mRS is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 to 6, with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
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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
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