Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT05001984
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    Alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks.

Study Details

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy.

Key Dates

Start date
Aug 1, 2021
Status verified
Feb 2025
Primary completion
Apr 15, 2025
Completion
Apr 15, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention group
    In addition to high-intensity statin and antiplatelet treatment, patients will receive treatment of alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks
  • No Intervention: Control group
    Patient will have high-intensity statin and antiplatelet treatment.

Primary Outcome Measure

The changes of intracranial atherosclerotic plaque: stenosis degree [ Time Frame: 26 weeks ]

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