Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447701
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
Effect of Interleukin-6 Receptor Inhibition for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerosis a Double-blind Randomized Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRIS-sICAS
Brief Summary:
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
Detailed Description:
Intracranial atherosclerosis ICAS is one of the most common causes of stroke worldwide and the currently recommended intensive pharmacologic and surgical treatments show only modest efficacy with approximately 20 of strokes still recurring for which there is no targeted treatment Tocilizumab is a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody that exerts anti-inflammatory effects by specifically binding to the IL-6 receptor and blocking IL-6 signal transduction Previous studies have shown that tocilizumab can effectively attenuate acute ischemic injury in the early stage of myocardial infarction and has potentially anti-atherosclerotic effects However application in ICAS not yet reported This study is a multicenter randomized double-blind placebo-controlled clinical trial which enrolled patients with symptomatic ICAS occurring within 72 hours of ischemic stroke or high-risk transient ischemic attack Patients who consented to participate in the study were randomly assigned in a 11 ratio to receive a single infusion of 320mg tocilizumab or placebo saline injection and patients were followed up to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None