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Clinical Trial of PCSK9 Inhibitor and Statin Treatment for Carotid Artery Stenosis | Clinical Trials | Clareo Health

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

A Randomized Clinical TRial on Inhibitor of PCSK9 and Statin Treatment for Carotid Artery Stenosis (TRIP-CAS)

NCT07036991•Changhai Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Key Dates

Start Date

July 30, 2025

Primary Completion Date

June 1, 2026

Completion Date

March 1, 2027

Last Updated

June 25, 2025

Enrollment

406

ESTIMATED participants

Conditions

Carotid Artery Stenosis

Interventions

Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe

DRUG

Rosuvastatin/Atorvastatin ± Ezetimibe

DRUG

Contacts

Qiang Li, MD, PhD

CONTACT

+86-13818803656 lqeimm@126.com

Yanhong Yan, MD, PhD

CONTACT

+86-18862195803 egyanhong@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)

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