NCT05741086

Evolocumab Added to Statin Therapy in Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)

Evolocumab Added to Statin Therapy in Patients With Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)---a Pilot Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of the trial is to investigate whether the experimental arms (receiving the Proprotein Convertase Subtilisin-Kexin Type 9 \[PCSK9\] inhibitor Evolocumab plus statin) could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up, compared with the control arm (taking statin) in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.

Detailed description

Intracranial atherosclerosis stenosis (ICAS) is one of the most common causes of stroke worldwide and is particularly prevalent in Asian. It accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (Intensive lipid lowering with statin to reach a low-density lipoprotein (LDL)-cholesterol lower than 1.8mmol/L, et al) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group. Evolocumab, a member of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. The FOURIER study showed that Evolocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease. The proposed pilot study will recruit 80 patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis, and directly compare Evolocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up.

Conditions

• Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis

Interventions

Type	Name	Description
DRUG	Evolocumab	evolocumab (140 mg every 2 weeks)
DRUG	Atorvastatin	Atorvastatin 20-40mg

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-02-23
• Last updated: 2023-06-02

Locations

1 site across 1 country: China