Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ische… (NCT07540741) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke
China1,000 participantsStarted 2025-12-03
Plain-language summary
This prospective multicenter cohort study aims to evaluate the effectiveness and safety of early PCSK9 inhibitor therapy in patients with large-artery atherosclerotic ischemic stroke. The study will compare early neurological improvement, lipid-lowering effect, 90-day functional outcome, recurrent cardio-cerebrovascular events, and safety outcomes between patients treated with evolocumab plus statin and those treated with statin alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years.
✓. Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria.
✓. Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset.
✓. Able to use evolocumab and statin medications in accordance with the physician's instructions and the prescribing information.
✓. No prior use of a PCSK9 inhibitor before enrollment.
Exclusion criteria
✕. Hemorrhagic transformation or other intracranial hemorrhage (including hemorrhagic infarction, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma), except cerebral microbleeds detected only by SWI.
✕. Prior intracranial or extracranial endovascular therapy before enrollment, planned acute endovascular therapy within 90 days, or planned surgery that may affect outcome assessment.
✕. Severe cardiac insufficiency：NYHA class III or IV.
✕. Severe hepatic dysfunction (ALT or AST \>3 x upper limit of normal) or severe renal dysfunction (serum creatinine \>2 mg/dL, eGFR \<30 mL/min/1.73 m2, or requiring dialysis).
What they're measuring
1
Proportion of participants with favorable functional outcome at Day 90
Timeframe: 90 ± 7 days after stroke onset
Trial details
NCT IDNCT07540741
SponsorFirst Affiliated Hospital of Harbin Medical University
✕. Participation in another interventional clinical study within 30 days before enrollment, or concurrent participation in another interventional study that may affect outcome assessment.
✕. Giant intracranial tumor, giant cerebral aneurysm, or arteriovenous malformation.