CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorWest China Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Evolocumab
- Serial photon-counting coronary computed tomography angiography
- Standard Lipid-Lowering Therapy
Treatment groups
233 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov