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

NCT07612774 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: WestChinaH-CVD-010
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary; Coronary Artery Disease

Keywords

acute coronary syndrome; coronary computed tomography angiography; proprotein convertase subtilisin/kexin type 9; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• HRP change

  From enrollment to the end of treatment at 52 weeks

Study Arms (2)

Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy

EXPERIMENTAL

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; Diagnostic Test: Serial photon-counting coronary computed tomography angiography

Active Comparator: Standard Lipid-Lowering Therapy

ACTIVE COMPARATOR

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; Drug: Standard Lipid-Lowering Therapy

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.

Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy

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.

Active Comparator: Standard Lipid-Lowering Therapy; Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy

Standard Lipid-Lowering Therapy DRUG

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

Active Comparator: Standard Lipid-Lowering Therapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients must meet the following 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 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.
• Agreement to complete baseline CCTA and laboratory tests within 7 days of enrollment and signed informed consent.
• Commitment to complete 52 weeks of follow-up.

You may not qualify if:

• 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.
• Known allergy or hypersensitivity to iodinated contrast media
• Hyperthyroidism or active thyroid disease
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Hypercholesterolemia, Autosomal Dominant, 3

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yong He

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaoyu Wang

CONTACT

86+18384252874; wxy2cd@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)