Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Harbin Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

NIHSS score 4-20 before treatment.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups