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

Sponsor
West China Hospital
Study ID
NCT07612774
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    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.
  • Serial photon-counting coronary computed tomography angiography — DIAGNOSTIC_TEST
    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.
  • Standard Lipid-Lowering Therapy — DRUG
    Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.

Study Details

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.

Key Dates

Start date
May 19, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
233 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy
    Participants randomized to this arm will receive early evolocumab in addition to standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features.
  • Active Comparator: Active Comparator: Standard Lipid-Lowering Therapy
    Participants randomized to this arm will receive guideline-directed standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features.

Primary Outcome Measure

Total atherosclerotic volume and stenosis severity [ Time Frame: From enrollment to the end of treatment at 52 weeks ]

Central Contacts

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