Clinical Trial of PCSK9 Inhibitor and Statin Treatment for Carotid Artery Stenosis

NCT ID: NCT07036991

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-03-01

Brief Summary

A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial.

Detailed Description

The trial is to evaluate the effect of ultra-intensive lipid-lowering therapy (PCSK9 inhibitor + rosuvastatin or atorvastatin, with/without ezetimibe) versus conventional lipid-lowering therapy (rosuvastatin or atorvastatin, with/without ezetimibe) on changes in atherosclerotic burden in patients with carotid artery stenosis.

Conditions

Carotid Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PCSK9 Inhibitor + Statin ± Ezetimibe Group

PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day

Group Type: EXPERIMENTAL

Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe

Intervention Type: DRUG

PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe

Statin ± Ezetimibe Group

Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day

Group Type: ACTIVE_COMPARATOR

Rosuvastatin/Atorvastatin ± Ezetimibe

Intervention Type: DRUG

Rosuvastatin/atorvastatin ± ezetimibe

Interventions

Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe

PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe

Intervention Type: DRUG

Rosuvastatin/Atorvastatin ± Ezetimibe

Rosuvastatin/atorvastatin ± ezetimibe

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Pinjing Hui, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Central Contacts

Qiang Li, MD, PhD

Role: CONTACT

lqeimm@126.com

+86-13818803656

Yanhong Yan, MD, PhD

Role: CONTACT

egyanhong@163.com

+86-18862195803

Other Identifiers

TRIP-CAS

Identifier Type: -

Identifier Source: org_study_id