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CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS (CAPRA-EVO)

2026年6月5日 更新者：Yong He、West China Hospital

A Single-center, Randomized Controlled Comparison of Effect of Evolocumab Versus Standard Lipid Lowering Therapy on Plaque Progression in Patients With Acute Coronary Syndrome by Serial PCCT(CAPRA-EVO Trial)

The CAPRA-EVO trial is a single-center, randomized, open-label study with blinded endpoint assessment comparing early evolocumab plus standard lipid-lowering therapy versus standard-of-care lipid-lowering therapy in patients with acute coronary syndrome after successful percutaneous coronary intervention. The study will use serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to assess changes in non-culprit coronary plaque burden and stenosis severity. Secondary outcomes include changes in high-risk plaque features, lipid and inflammatory biomarkers, cardiovascular events, and safety outcomes. The trial aims to determine whether early intensive LDL-C lowering with evolocumab can reduce coronary plaque progression and support PCCT-CCTA as a noninvasive tool for monitoring atherosclerotic plaque dynamics.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

233

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Xiaoyu Wang
  • 电话号码：86+18384252874
  • 邮箱：wxy2cd@yeah.net

学习地点

  • 中国
    • Sichuan
      • Chengdu、Sichuan、中国
        • 招聘中
        • West China Hospital of Sichuan University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Eligible patients must meet the following criteria:

  • Age between 40 and 75 years.
  • Diagnosis of ACS, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) or unstable angina (UA).
  • Successful PCI treatment, with post-procedural TIMI grade 3 flow and residual stenosis <30% and atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event).
  • Suboptimal LDL-C control: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol/L; or Statin-naive patients must have an LDL-C level ≥3.2 mmol/L.
  • Agreement to complete baseline CCTA and laboratory tests within 7 days of enrollment and signed informed consent.
  • Commitment to complete 52 weeks of follow-up.

Exclusion Criteria:

  • History of coronary artery bypass grafting (CABG).
  • History of valve surgery.
  • History of PCI treatment before the index ACS event
  • Complex bifurcation lesions (Medina 1,1,1).
  • Use of PCSK9 inhibitors (e.g., evolocumab, alirocumab) or potent CYP3A4 inhibitors (e.g., itraconazole) within the last 12 months.
  • Known intolerance to statins, evolocumab, or other investigational drugs related to the study.
  • Hepatic or renal insufficiency (eGFR <60 mL/min/1.73m² or ALT/AST >3 times the upper limit of normal).
  • Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
  • Uncontrolled heart failure (NYHA class III-IV) or malignant arrhythmias.
  • Known allergy or hypersensitivity to iodinated contrast media
  • Hyperthyroidism or active thyroid disease
  • Pregnancy or breastfeeding (or plans for pregnancy within the next year).
  • Life expectancy of less than 1 year (e.g., due to advanced malignancy).
  • Participation in another interventional clinical trial within the past 3 months.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy
Participants randomized to this arm will receive early evolocumab in addition to standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features.
药品：Evolocumab
Evolocumab will be administered early after randomization in participants assigned to the experimental arm, in addition to standard-of-care lipid-lowering therapy. The treatment is intended to achieve intensive low-density lipoprotein cholesterol reduction and to evaluate its effect on coronary plaque progression or stabilization over 52 weeks.
诊断测试：Serial photon-counting coronary computed tomography angiography
All participants will undergo photon-counting coronary computed tomography angiography at baseline and at 52 weeks. Imaging will be used to assess changes in total atherosclerotic volume, stenosis severity, and high-risk plaque features in non-culprit coronary vessels.
有源比较器：Active Comparator: Standard Lipid-Lowering Therapy
Participants randomized to this arm will receive guideline-directed standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features.
诊断测试：Serial photon-counting coronary computed tomography angiography
All participants will undergo photon-counting coronary computed tomography angiography at baseline and at 52 weeks. Imaging will be used to assess changes in total atherosclerotic volume, stenosis severity, and high-risk plaque features in non-culprit coronary vessels.
药品：Standard Lipid-Lowering Therapy
Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Total atherosclerotic volume and stenosis severity
大体时间：From enrollment to the end of treatment at 52 weeks
a. Total atherosclerotic volume (TAV) at the whole-non-culprit-vessel level: Change from baseline CTA (week 0) to endpoint CTA(week 52).
From enrollment to the end of treatment at 52 weeks
b. Stenosis severity at the target lesion level (defined as luminal stenosis ≥50%, particularly in left main coronary artery [LMCA] or proximal left anterior descending artery [LAD] OR presence of ≥2 high-risk plaque features)
大体时间：From enrollment to the end of treatment at 52 weeks
From enrollment to the end of treatment at 52 weeks

次要结果测量

结果测量
措施说明
大体时间
HRP change
大体时间：From enrollment to the end of treatment at 52 weeks
Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52).
From enrollment to the end of treatment at 52 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

West China Hospital

调查人员

  • 研究主任：Yong He、West China Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月19日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年1月31日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月23日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • WestChinaH-CVD-010

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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