[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595787":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":26,"responsibleParty":48,"collaborators":50,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PCSK9 Inhibitor + Statin ± Ezetimibe Group","EXPERIMENTAL","PCSK9 inhibitor (biweekly injections) + rosuvastatin\u002Fatorvastatin ± ezetimibe, initiated on randomization day",[13],"Drug: Evolocumab (biweekly injections) + Rosuvastatin\u002FAtorvastatin ± Ezetimibe",{"label":15,"type":16,"description":17,"interventionNames":18},"Statin ± Ezetimibe Group","ACTIVE_COMPARATOR","Rosuvastatin\u002Fatorvastatin ± ezetimibe, continued or initiated on randomization day",[19],"Drug: Rosuvastatin\u002FAtorvastatin ± Ezetimibe",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Evolocumab (biweekly injections) + Rosuvastatin\u002FAtorvastatin ± Ezetimibe","PCSK9 inhibitor (biweekly injections) + rosuvastatin\u002Fatorvastatin ± ezetimibe",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rosuvastatin\u002FAtorvastatin ± Ezetimibe","Rosuvastatin\u002Fatorvastatin ± ezetimibe",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Jianmin Liu","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Pinjing Hui, MD, PhD","The First Affiliated Hospital of Soochow University",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Qiang Li, MD, PhD","CONTACT","+86-13818803656","lqeimm@126.com",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":47},"Yanhong Yan, MD, PhD","+86-18862195803","egyanhong@163.com",{"type":49,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[51],{"name":37,"class":6},"100595787","phase-4-clinical-trial-of-pcsk9-inhibitor-and-statin-treatment-for-carotid-artery-stenosis-100595787",false,"NCT07036991","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)","TRIP-CAS","Inclusion Criteria:\n\nClinical inclusion criteria:\n\n1. Age ≥ 18 years.\n2. Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.\n3. Modified Rankin Scale (mRS) score ≤ 2\n4. Signed informed consent form obtained from the subject\n\nUltrasound Inclusion Criteria:\n\nCarotid 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).\n\nExclusion Criteria:\n\n1. Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.\n2. Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus\u002Fvegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic\u002Fparoxysmal atrial fibrillation. (Confound ASCVD outcome assessment.)\n3. History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.\n4. History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.\n5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.\n6. History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease.\n7. Severe neurological deficits impairing independent living; diagnosed dementia\u002Fpsychiatric disorders interfering with follow-up; or life expectancy \\\u003C3 years due to other conditions.\n8. Severe\u002Funstable comorbidities: Severe heart failure (NYHA Class III\u002FIV or LVEF \\\u003C30%), Renal failure (serum creatinine \\>264 μmol\u002FL or creatinine clearance \\\u003C0.6 mL\u002Fs), Severe hepatic dysfunction (ALT\u002FAST \\>3× upper limit of normal), CK \\>5× upper limit of normal, Active malignancy.\n9. Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment.\n10. 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\u002Fritonavir, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets), mbitasvir\u002Fparitaprevir\u002Fritonavir 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.\n11. Pregnancy or lactation.\n12. Concurrent participation in another trial that may affect outcome assessment.\n13. Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial.\n14. Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.","ALL","18 Years",{"count":63,"type":64},406,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial.",[70],"Carotid Artery Stenosis",[72,70],"CAS","NOT_YET_RECRUITING","2025-06-23",{"date":76,"type":77},"2025-06-25","ACTUAL",{"date":79,"type":64},"2025-07-30",{"date":81,"type":64},"2027-03-01",{"name":5,"class":6}]