Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis

Launched by ZHUJIANG HOSPITAL · Jun 6, 2024

Keywords

ClinConnect Summary

The IRIS-sICAS trial is a clinical study that aims to find out if an injection called tocilizumab can help reduce the chances of having a new ischemic stroke (a type of stroke caused by blocked blood flow to the brain) and improve the outcomes for patients who have symptoms of intracranial atherosclerosis, which is a condition where the arteries in the brain become narrowed. This study is designed for adults aged 18 and older who have recently experienced a stroke or a transient ischemic attack (TIA), also known as a "mini-stroke," and are showing signs of this artery narrowing.

To participate, patients must have recently had a stroke or TIA related to significant narrowing of their brain arteries and must be willing to follow the study's protocols. They will receive either the tocilizumab injection or a placebo (a fake treatment) without knowing which one they got. Throughout the study, participants will be monitored closely to assess the safety and effectiveness of the treatment. It’s important to note that certain health conditions and recent medical treatments may prevent someone from joining the trial, so potential participants should discuss their medical history with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Willing to be followed up as required by the clinical study protocol.
• Exclusion Criteria:
• • 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%.
• • Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus; any known vasculitic disease.
• • Extracranial stenosis ≥50%, subclavian arterial stenosis≥50% or subclavian steal syndrome.
• • Previous interventions for intracranial arterial stenosis.
• • Concurrent intracranial tumors, intracranial aneurysms or arteriovenous malformations
• • Neutrophil \< 2×10 9/L.
• • Platelet \< 100×10 9/L.
• • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal.
• • Active infections including localized.
• • Evidence of HIV or hepatitis B positivity.
• • Positive tuberculosis-related tests.
• • Concurrent peptic ulcer, diverticulitis or inflammatory bowel disease.
• • Concurrent malignant tumors, recent bone marrow transplant or recent organ transplant.
• • Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.
• • Known allergy to tocilizumab or excipients.
• • Use of immunosuppressive drugs or systemic use of antibiotics.
• • Received any live or live attenuated vaccine within 4 weeks prior to enrollment or plan to receive a live or live attenuated vaccine during the study.
• • History of demyelination or presence of neurological symptoms suggestive of demyelination.
• • Previously existing neurological or psychiatric disorders that could potentially confuse neurological function assessment.
• • An expected survival less than 90 days.
• • Participation in another interventional clinical study.
• • Patients unsuitable for enrollment in the clinical trial according to investigators decision making.