Studio CARUSO (CARotid plaqUe StabilizatiOn and regression with evolocumab): stabilizzazione morfologica e regressione della placca carotidea con evolocumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and carotid plaque regression, at 6 and 12 months, respectively
研究概览
简要总结
evaluate the superiority of evolocumab in addition to ongoing LLT compared to LLT alone with regards to: a) morphological stabilization of the carotid plaque at 6 months, defined as regression of the ulcerations and "soft" components and obtaining a regular morphology of the plaque with prevalence of fibrous atheroma (type III and IV), evaluated with DUS and/or MRI, or CT b) regression of the carotid plaque at 12 months, defined as reduction in the extent of stenosis and PSV of at least 5% compared to baseline values.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •asymptomatic patients with carotid stenosis mono or bilateral magnitude ≥50% and LDL-C values ≥100 mg/dL despite maximal LLT...
排除标准
- •age <18 years, known intolerance to evolocumab, previous or current therapy with PCSK9 inhibitors, previous stroke or TIA, total carotid occlusion, non-subscription of informed consent
结局指标
主要结局
Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and carotid plaque regression, at 6 and 12 months, respectively
Superiority of evolocumab added to ongoing LLT versus ongoing LLT in determining morphological stabilization and carotid plaque regression, at 6 and 12 months, respectively
次要结局
未报告次要终点
研究者
Clinical Trial Unit
Scientific
Azienda Ospedaliera Ordine Mauriziano Di Torino