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

Summary

The CAPER-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.

Eligibility

Inclusion 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 with atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event).
* Statin therapy: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol/L.
* Statin-naive patients must have an LDL-C level ≥3.2 mmol/L.
* Agreement to complete baseline CTA and laboratory tests within 7 days of enrollment.
* 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.
* Allergy or intolerance to contrast agents.
* 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.

Conditions3

Interventions2

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