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)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 233
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Serial photon-counting coronary computed tomography angiography (Diagnostic Test)
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.
干预措施: Serial photon-counting coronary computed tomography angiography (Diagnostic Test)
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.
干预措施: Standard Lipid-Lowering Therapy (Drug)