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CAPER-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS

NCT07612774 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2026-05-29

No results posted yet for this study

Summary

The CAPER-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.

Conditions

Interventions

DRUG

Evolocumab

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_TEST

Serial 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.

DRUG

Standard Lipid-Lowering Therapy

Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Yong He · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-19
Primary Completion
2028-12-31
Completion
2029-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612774 on ClinicalTrials.gov