CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
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)
West China Hospital
233 participants
May 19, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria14
- 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.
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Interventions
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.
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.
Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07612774