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

ConditionCarotid Artery Stenosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

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

  • Rosuvastatin/Atorvastatin ± Ezetimibe

    Drug

    Rosuvastatin/atorvastatin ± ezetimibe

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: PCSK9 Inhibitor + Statin ± Ezetimibe GroupExperimental treatment 1 intervention
Group B: Statin ± Ezetimibe GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
180±7 days

Secondary outcomes

1

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

Time frame
30±3 days
2

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

Time frame
90±3 days
3

Carotid plaque burden rate at 90±3 days

Time frame
90±3 days
4

Carotid plaque diameter stenosis at 90±3 days

Time frame
90±3 days

Other outcomes

1

Deaths within 180±7 days after enrolment

Time frame
within 180±7 days after enrolment
2

SAEs within 180±7 days after enrolment

Time frame
within 180±7 days after enrolment
3

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

Time frame
within 180±7 days after enrolment
4

Deaths within 365±30 days after enrolment

Time frame
within 365±30 days after enrolment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

The First Affiliated Hospital of Soochow University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: