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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06080256
Phase
PHASE3
Status
Unknown

Conditions

  • Atherosclerotic Plaque
  • Intracranial Atherosclerosis
  • Stenosis

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    alirocumab (75 mg every 2 weeks)
  • Atorvastatin — DRUG
    Atorvastatin 20-40mg

Study Details

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.

Key Dates

Start date
Dec 30, 2023
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab added to statin therapy
    Alirocumab (75 mg every 2 weeks for 6 months) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management.
  • Active Comparator: Statin therapy
    Atorvastatin 20-40mg. Anti-platelet aggregation and risk factor management in both arms.

Primary Outcome Measure

Plaque burden (PB) [ Time Frame: This will be assessed at 6 months after recruitment. ]

Central Contacts

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