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

A Single-center, Randomized Controlled Comparison of Effect of Evolocumab Versus Standard Lipid Lowering Therapy on Plaque Progression in Patients With Acute Coronary Syndrome by Serial PCCT(CAPER-EVO Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary
• Intervention / Treatment: Drug: Evolocumab; Diagnostic test: Serial photon-counting coronary computed tomography angiography; Drug: Standard Lipid-Lowering Therapy

• Study Type: Interventional
• Enrollment (Estimated): 233
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoyu Wang; Phone Number: 86+18384252874; Email: wxy2cd@yeah.net

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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 with atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event).
• Statin therapy: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol/L.
• Statin-naive patients must have an LDL-C level ≥3.2 mmol/L.
• Agreement to complete baseline CTA and laboratory tests within 7 days of enrollment.
• 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.
• Allergy or intolerance to contrast agents.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 52 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRP change	Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52).	From enrollment to the end of treatment at 52 weeks

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Yong He, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 19, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; acute coronary syndrome; coronary computed tomography angiography; proprotein convertase subtilisin/kexin type 9
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Acute Coronary Syndrome; Hypercholesterolemia, Autosomal Dominant, 3; evolocumab
• Other Study ID Numbers: WestChinaH-CVD-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes