NCT06080256

Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)

Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)----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 lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with asymptomatic 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. On the other hand, in view of the ready availability of MRA or CTA , asymptomatic ICAS (ICAS without causing TIA or stroke) can be found at heath checkup. It would be of great significance to take measures to prevent TIA/stroke in those asymptomatic ICAS. Alirocumab, 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 ODYSSEY OUTCOMES study showed that Alirocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease. This pilot study will recruit 80 patients with asymptomatic intracranial artery stenosis, and directly compare Alirocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up.

Conditions

• Intracranial Atherosclerosis
• Atherosclerotic Plaque
• Stenosis

Interventions

Type	Name	Description
DRUG	Alirocumab	alirocumab (75 mg every 2 weeks)
DRUG	Atorvastatin	Atorvastatin 20-40mg

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-10-12
• Last updated: 2023-12-21

Locations

1 site across 1 country: China