Coronary, Coronary Artery Disease
Conditions
Keywords
acute coronary syndrome, coronary computed tomography angiography, proprotein convertase subtilisin/kexin type 9, randomized controlled trial
Brief 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.
Interventions
DRUGEvolocumab
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.
DIAGNOSTIC_TESTSerial 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.
Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HRP change | From enrollment to the end of treatment at 52 weeks | Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52). |
Countries
China
Contacts
CONTACTXiaoyu Wang
STUDY_DIRECTORYong He
West China Hospital
Outcome results
None listed