NCT07036991招募中4 期
A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis (TRIP-CAS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Change in plaque burden rate at the most stenotic carotid site at 180±7 days
研究概览
简要总结
A multicenter cohort study
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical inclusion criteria:
- •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
- •Ultrasound Inclusion Criteria:
- •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).
排除标准
- •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.
研究组 & 干预措施
Non-exposed Group: Statin ± Ezetimibe Group
Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day
干预措施: Rosuvastatin/Atorvastatin ± Ezetimibe (Drug)
Exposure Group: PCSK9 Inhibitor + Statin ± Ezetimibe Group
PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day
干预措施: PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe (Drug)
结局指标
主要结局
Change in plaque burden rate at the most stenotic carotid site at 180±7 days
时间窗: 180±7 days
次要结局
- Lipid profile (TG/TC/LDL-C/HDL-C), liver function (ALT, AST), CK at 30±3 days(30±3 days)
- Lipid profile: TG/TC/LDL-C/HDL-C; liver function: ALT, AST, CK at 180±7 days(180±7 days)
- Time to first major vascular event within 365±30 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)(within 365±30 days)
- 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)
- Plaque stability (hypoechoic regions, fibrous cap integrity, ulceration, plaque score) at 90±3 days(90±3 days)
- Lipid profile: TG/TC/LDL-C/HDL-C/Lp-a/ApoA1, ApoB; liver function: ALT, AST, CK, CRP at 180±7 days(180±7 days)
- Plaque burden rate at the most stenotic cross-sectional site of the carotid artery at 180±7 days(180±7 days)
- Plaque diameter stenosis at 180±7 days(180±7 days)
- Plaque dimensions (length × thickness) at 180±7 days(180±7 days)
- Plaque stability (hypoechoic regions, fibrous cap integrity, ulceration, plaque score) at 180±7 days(180±7 days)
- mRS score at 180±7 days(180±7 days)
- Time to first major vascular event within 180±7 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)(within 180±7 days)
- mRS score at 365±30 days(365±30 days)
研究者
研究点 (1)
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