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.
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.
Standard Lipid-Lowering Therapy: Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.
Study summary
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Total atherosclerotic volume and stenosis severity — 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).
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) — From enrollment to the end of treatment at 52 weeks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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