A multicenter cohort study
Age ≥ 18 years.
Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.
Modified Rankin Scale (mRS) score ≤ 2
Signed informed consent form obtained from the subject
Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.
Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus/vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic/paroxysmal atrial fibrillation. (Confound ASCVD outcome assessment.)
History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.
History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.
For patients with mild to moderate carotid artery stenosis, those who are confirmed to meet the clinical inclusion and exclusion criteria and whose carotid artery plaque burden rate is confirmed to be ≥ 30% through carotid artery ultrasound examination can be registered.
Cohort
Prospective
PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe
DrugPCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe
Rosuvastatin/Atorvastatin ± Ezetimibe
DrugRosuvastatin/atorvastatin ± ezetimibe
Change in plaque burden rate at the most stenotic carotid site at 180±7 days
Lipid profile (TG/TC/LDL-C/HDL-C), liver function (ALT, AST), CK at 30±3 days
Lipid profile: TG/TC/LDL-C/HDL-C; liver function: ALT, AST, CK at 180±7 days
Plaque burden rate at the most stenotic cross-sectional site of the carotid artery at 180±7 days
Plaque diameter stenosis at 180±7 days
Deaths within 180±7 days after enrolment
SAEs within 180±7 days after enrolment
ALT/AST >2× upper limit, CK >3× upper limit within 180±7 days after enrolment
Deaths within 365±30 days after enrolment
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Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
