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
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
Treatments tested in this trial
- Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe
- Rosuvastatin/Atorvastatin ± Ezetimibe
Treatment groups
406 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Source ClinicalTrials.gov