CARotid plaqUe StabilizatiOn and Regression With Evolocumab: the CARUSO Study
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Morphological carotid plaque stabilization
研究概览
简要总结
The CARUSO trial aims at investigating the efficacy of evolocumab in promoting carotid plaque morphological stabilization and regression as compared to traditional lipid lowering therapy (LLT). Primary end-point of the study is the superiority of evolocumab on top of ongoing LLT versus ongoing LLT in carotid plaque morphological stabilization and regression at 6 and 12 months, respectively. Secondary end-points are: LDL-Cholesterol (LDL-C) absolute and percentage changes in the two groups at 12 month follow-up, and adverse cerebrovascular and cardiac events at 12 and 24 months
详细描述
Optimal lipid-lowering therapy (LLT) is a mainstay for the therapeutic management of atherosclerotic vascular disease. Cardiac and cerebrovascular adverse events and progression of atherosclerosis are, indeed, reduced in proportion to the achieved LDL cholesterol (LDL-C) levels.In addition, regression of atherosclerotic plaques with optimal LLT has been observed. However, optimal LLT with statin and ezetimibe, might be limited by the onset of adverse effects (i.e. disabling myalgias, diarrhea) with are usually dose -dependent, and the maximum tolerated statin dose might be insufficient to reach the recommended LDL-C goals. The advent of proprotein convertase subtilisin kexin type 9 inhibitors (PCSK9i) has allowed the achievement of very low LDL-C levels, and the fulfillment of the recommended LDL-C targets. However, while the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding carotid plaque regression following therapy with PCSK9i. Only a few case reports have been published, and no observational study has been carried out so far. Furthermore, morphological carotid plaque stabilization has a prognostic role, and the possibility of its early achievement with PCSK9i may be relevant, especially in the context of percutaneous or surgical carotid interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single blinded study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asymptomatic patients with uni- or bilateral carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dL despite ongoing lipid lowering therapy
排除标准
- •age <18 or ≥81 years old
- •known intolerance to evolocumab
- •ongoing or previous treatment with PCSK9i
- •prior stroke or transient ischemic attack
- •total carotid occlusion
- •major active infection or major hematologic, renal, hepatic, or endocrine dysfunction
- •malignancy with life expectancy below 24 months
- •failure to sign informed consent
研究组 & 干预措施
Evolocumab
Subcutaneous evolocumab 140 mg will be administered every 2 weeks on top of optimal lipid-lowering therapy
干预措施: Evolocumab (Drug)
Evolocumab
Subcutaneous evolocumab 140 mg will be administered every 2 weeks on top of optimal lipid-lowering therapy
干预措施: lipid-lowering therapy (LLT) (Other)
Standard
No further treatment besides optimal lipid-lowering therapy will be administered
干预措施: lipid-lowering therapy (LLT) (Other)
结局指标
主要结局
Morphological carotid plaque stabilization
时间窗: Six months
Morphological stabilization of the carotid plaque evaluated with Carotid duplex ultra-sonography
Carotid plaque regression
时间窗: 12 months
Carotid plaque regression evaluated with Carotid duplex ultra-sonography and defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared to baseline.
次要结局
- Changes of LDL-C(12 months)
- Major adverse cerebrovascular events(12 and 24 months)
研究者
Tiziana Claudia Aranzulla
MD, MSc
Azienda Ospedaliera Ordine Mauriziano di Torino