What is this study trying to find out about carotid artery stenosis?

This study aims to evaluate how ultra-intensive lipid-lowering therapy combining a PCSK9 inhibitor with statins compares to conventional statin therapy alone in reducing the build-up of plaque in the carotid arteries. The research focuses on understanding changes in artery narrowing and related health outcomes. It is sponsored by Changhai Hospital.

Who may be eligible for this carotid artery stenosis clinical trial?

Adults aged 18 years and older with mild-to-moderate carotid artery stenosis confirmed by imaging and a modified Rankin Scale score of 2 or less may be eligible. People who are pregnant or breastfeeding or have used certain cholesterol-lowering drugs recently may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this carotid artery stenosis clinical trial?

Study-related care, including all study visits and treatments, is provided at no cost. However, personal travel and other expenses may not be covered and can vary. Participants should plan accordingly.

Actively Recruiting

Age: 18Years +

All Genders

ID07036991

Study Comparing PCSK9 Inhibitor Plus Statin Versus Statin Alone for Patients with Carotid Artery Stenosis

Led by Changhai Hospital · Updated on 2026-08-07

406

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying patients with carotid artery stenosis to compare the effects of ultra-intensive lipid-lowering therapy using a PCSK9 inhibitor combined with rosuvastatin or atorvastatin, with or without ezetimibe, against conventional lipid-lowering therapy using rosuvastatin or atorvastatin, with or without ezetimibe. The study aims to evaluate changes in the atherosclerotic plaque burden in these patients. Participants will either receive a combination of PCSK9 inhibitor injections every two weeks plus rosuvastatin or atorvastatin with or without ezetimibe, starting on the day of randomization, or they will continue or initiate treatment with rosuvastatin or atorvastatin with or without ezetimibe alone. The study is observational and involves two groups one exposed to the PCSK9 inhibitor plus statin treatment and the other receiving statin therapy alone. Throughout the study, participants will be monitored for changes in plaque burden at the most narrowed carotid site after about 180 days. Other assessments include lipid profiles, liver function tests, creatine kinase levels, plaque characteristics, and the occurrence of major vascular events up to 365 days. Researchers will also evaluate functional status using the modified Rankin Scale. The trial is expected to conclude in June 2027 with ongoing monitoring during the study period.

CONDITIONS

Brief Title

A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Diagnosed with asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA
Modified Rankin Scale (mRS) score of 2 or less
Signed informed consent given
Carotid ultrasound showing plaque burden rate of 30% or higher at the most narrowed carotid site

You will not qualify if you...

Non-atherosclerotic carotid stenosis such as arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, vasospasm, or recanalized embolism
Known cardioembolic sources including mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus, recent myocardial infarction, dilated cardiomyopathy, or atrial fibrillation
History of vascular interventions or surgery within 30 days before enrollment or planned surgery within six months
History of ischemic stroke, transient ischemic attack, or intracranial hemorrhage before enrollment
Pre-existing brain tumors, cerebral aneurysm, or arteriovenous malformations
History of thromboembolic diseases or coronary atherosclerotic heart disease
Severe neurological deficits, dementia, psychiatric disorders interfering with follow-up, or life expectancy less than 3 years
Severe or unstable heart, kidney, or liver disease, active cancer
Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment
Use of strong cytochrome P-450 3A4 inhibitor drugs within one month before randomization or anticipated during the study
Pregnancy or lactation
Participation in another trial affecting outcome assessment
Other conditions posing significant harm risk as judged by investigators
Other vascular lesions likely to cause short-term ischemic events or surgeries

Research Team

Qiang Li, MD, PhD

Yanhong Yan, MD, PhD

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Study Comparing PCSK9 Inhibitor Plus Statin Versus Statin Alone for Patients with Carotid Artery Stenosis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria