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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05741086
Phase
PHASE3
Status
Unknown

Conditions

  • Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis

Eligibility Criteria

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

Interventions

  • Evolocumab — DRUG
    evolocumab (140 mg every 2 weeks)
  • Atorvastatin — DRUG
    Atorvastatin 20-40mg

Study Details

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.

Key Dates

Start date
Apr 15, 2023
Status verified
Jun 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

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

Arms

  • Experimental: Evolocumab added to statin therapy
    Evolocumab (140 mg every 2 weeks for 1 year) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management in both arms.
  • 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 1 year after recruitment. ]

Central Contacts