๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ1.8 mmol/L; or Statin-naive patients must have an LDL-C level โฅ3.2 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/1.73mยฒ 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.
๐
What it tests
- Evolocumab
- Serial photon-counting coronary computed tomography angiography
- Standard Lipid-Lowering Therapy
Tangdu Hospital, Air Force Medical University
Xiโan, China
West China Hospital of Sichuan University
Chengdu, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.