Design of the “EAST” strategy in patients with symptomatic intracranial atherosclerotic stenosis

Abstract

Introduction: There is a high risk of stroke occurrence and recurrence in patients with intracranial atherosclerotic stenosis (ICAS) despite aggressive medical therapy. Evolocumab is a monoclonal antibody which can inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) and effectively reduce the level of low-density lipoprotein cholesterol. We hypothesize that evolocumab added to statin therapy (EAST) can stabilize intracranial plaques in patients with symptomatic ICAS. Methods and analysis: This is a prospective, randomized, open-label, blinded end-point study, which will assess the efficacy and safety of evolocumab in patients with symptomatic ICAS. Eighty patients who suffer a stroke/transient ischemic attack (TIA) caused by ICAS recently will be randomly allocated in a 1:1 ratio to the evolocumab plus statin treatment group or the statin treatment group. High resolution vessel wall magnetic resonance imaging (HR-vwMRI) will be performed at recruitment and after 6 months and 12 months. The primary outcome is changes in plaque characteristics assessed by HR-vwMRI at 6th month and 12th month after treatment. Cognitive and neurological function will also be evaluated at recruitment and follow-up. This trial is being conducted at the first affiliated hospital of Nanjing medical university, China. Ethics and dissemination: All participants will sign written informed consents. Peer-reviewed articles will be published to disseminate study outcomes. Clinical trial registration: ClinicalTrials.gov, identifier: NCT05741086.