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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Evolocumab
DrugEvolocumab 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
Diagnostic testAll 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
DrugParticipants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.
Treatment groups
232 Participants
are divided into 2 treatment groupsGroup A: Experimental: Evolocumab Plus Standard Lipid-Lowering TherapyExperimental treatment 2 interventions
Group B: Active Comparator: Standard Lipid-Lowering TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Total atherosclerotic volume and stenosis severity
a. Total atherosclerotic volume (TAV) at the whole-non-culprit-vessel level: Change from baseline CTA (week 0) to endpoint CTA(week 52).
Time frame
From enrollment to the end of treatment at 52 weeks2
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)
Time frame
From enrollment to the end of treatment at 52 weeksSecondary outcomes
1
HRP change
Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52).
Time frame
From enrollment to the end of treatment at 52 weeksSponsors and contacts
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Source ClinicalTrials.gov