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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат 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.
• Диагностический тест 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.
• Препарат Standard Lipid-Lowering Therapy
  Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.

Первичные конечные точки

• Total atherosclerotic volume and stenosis severity [Срок оценки: 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) [Срок оценки: From enrollment to the end of treatment at 52 weeks]

Вторичные конечные точки (1)

• HRP change [Срок оценки: From enrollment to the end of treatment at 52 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07612774 · WestChinaH-CVD-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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