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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: West China Hospital • ClinicalTrials.gov ID: NCT07612774

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Evolocumab (Drug)
    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.
  • Serial photon-counting coronary computed tomography angiography (Diagnostic test)
    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.
  • Standard Lipid-Lowering Therapy (Drug)
    Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.

Eligibility criteria

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.

Conditions

Coronary Coronary Artery Disease

Locations

  • Tangdu Hospital, Air Force Medical University — Xi’an, Shanxi, China
  • West China Hospital of Sichuan University — Chengdu, Sichuan, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record