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

NCT07036991 | Not Yet Recruiting Phase 4

• 1 other identifier: TRIP-CAS
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Carotid Artery Stenosis

Keywords

CAS; Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Change in plaque burden rate at the most stenotic carotid site at 180±7 days

  180±7 days

Secondary Outcomes (15)

• Lipid profile (TG/TC/LDL-C/HDL-C), liver function (ALT, AST), CK, CRP at 30±3 days

  30±3 days

• Lipid profile (TG/TC/LDL-C/HDL-C/Lp(a)/ApoA1/ApoB), liver function (ALT, AST), CK, CRP at 90±3 days

  90±3 days

• Carotid plaque burden rate at 90±3 days

  90±3 days

• Carotid plaque diameter stenosis at 90±3 days

  90±3 days

• Carotid plaque dimensions (length × thickness) at 90±3 days

  90±3 days

Other Outcomes (6)

• Deaths within 180±7 days after enrolment

  within 180±7 days after enrolment

• SAEs within 180±7 days after enrolment

  within 180±7 days after enrolment

• ALT/AST >2× upper limit, CK >3× upper limit within 180±7 days after enrolment

  within 180±7 days after enrolment

Study Arms (2)

PCSK9 Inhibitor + Statin ± Ezetimibe Group

EXPERIMENTAL

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

Drug: Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe

Statin ± Ezetimibe Group

ACTIVE COMPARATOR

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

Drug: Rosuvastatin/Atorvastatin ± Ezetimibe

Interventions

Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe DRUG

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

PCSK9 Inhibitor + Statin ± Ezetimibe Group

Rosuvastatin/Atorvastatin ± Ezetimibe DRUG

Rosuvastatin/atorvastatin ± ezetimibe

Statin ± Ezetimibe Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.
• Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
• History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease.
• Severe neurological deficits impairing independent living; diagnosed dementia/psychiatric disorders interfering with follow-up; or life expectancy \<3 years due to other conditions.
• 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.
• Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment.
• 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.
• Pregnancy or lactation.
• Concurrent participation in another trial that may affect outcome assessment.
• Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial.
• Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.

Sponsors & Collaborators

• Changhai Hospital: lead
• The First Affiliated Hospital of Soochow University: collaborator

MeSH Terms

Conditions

Carotid Stenosis

Interventions

evolocumab; Rosuvastatin Calcium; liptruzet

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Pinjing Hui, MD, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Li, MD, PhD

CONTACT

+86-13818803656; lqeimm@126.com

Yanhong Yan, MD, PhD

CONTACT

+86-18862195803; egyanhong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 25, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4.Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5.The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.