Ultra-Intensive Lipid-Lowering Therapy in Carotid Artery Stenosis: PCSK9 Inhibitor Plus Statin vs Statin Alone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational cohort compares ultra-intensive lipid-lowering therapy (PCSK9 inhibitor with rosuvastatin or atorvastatin, with or without ezetimibe) to conventional lipid-lowering therapy (rosuvastatin or atorvastatin, with or without ezetimibe) in adults with asymptomatic mild-to-moderate carotid artery stenosis. Participants are evaluated for changes in atherosclerotic burden over time using imaging. Eligibility includes age 18 or older, confirmation of stenosis without planned intervention, a functional status of mRS ≤ 2, and adequate plaque burden on ultrasound. Non-atherosclerotic causes of stenosis and recent major cardiac events are among exclusion criteria. The study is led by Changhai Hospital with collaboration from The First Affiliated Hospital of Soochow University at multiple sites in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Clinical inclusion criteria:

1. Age ≥ 18 years.
2. Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.
3. Modified Rankin Scale (mRS) score ≤ 2
4. Signed informed consent form obtained from the subject

Ultrasound Inclusion Criteria:

Carotid ultrasound showing a plaque burden rate ≥30% at the most stenotic cross-sectional site of the carotid artery (common carotid artery or proximal C1 segment of the internal carotid artery).

Exclusion Criteria:

1. Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.
2. 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.)
3. History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.
4. History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.
5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
6. History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease.
7. Severe neurological deficits impairing independent living; diagnosed dementia/psychiatric disorders interfering with follow-up; or life expectancy \<3 years due to other conditions.
8. Severe/unstable comorbidities: Severe heart failure (NYHA Class III/IV or LVEF \<30%), Renal failure (serum creatinine \>264 μmol/L or creatinine clearance \<0.6 mL/s), Severe hepatic dysfunction (ALT/AST \>3× upper limit of normal), CK \>5× upper limit of normal, Active malignancy.
9. Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment.
10. The subjects have taken strong inhibitor drugs of cytochrome P-450 3A4 (including: adagrasib, atazanavir, ceritinib, clarithromycin, darunavir, idelalisib, indinavir, itraconazole, ketoconazole, levonorgestrel, lonafarnib, lopinavir, mifepristone, nefazodone, nelfinavir, nirmatrelvir/ritonavir, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets), mbitasvir/paritaprevir/ritonavir and dasabuvir, posaconazole, co-formulations containing ritonavir and ritonavir itself, saquinavir, erythromycin, tucatinib, voriconazole) within one month before randomization, or may require such drugs during the study period.
11. Pregnancy or lactation.
12. Concurrent participation in another trial that may affect outcome assessment.
13. Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial.
14. Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.

Where it's running

• Changhai Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Jianmin Liu — Changhai Hospital
• Study coordinator: Qiang Li, MD, PhD
• Email: lqeimm@126.com
• Phone: +86-13818803656

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.