Early LDL-C lowering with evolocumab after ACS to see if it slows plaque progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center, randomized, open-label study with blinded endpoint assessment, patients with acute coronary syndrome who had successful PCI are assigned to early evolocumab plus standard lipid therapy versus standard therapy alone. Researchers monitor plaque burden and stenosis using serial photon-counting coronary CT angiography at baseline and 52 weeks, along with measurements of high-risk plaque features, lipid/inflammatory biomarkers, and safety outcomes. The goal is to see if aggressive LDL-C lowering can slow plaque progression and whether CCTA can effectively track these changes noninvasively. Secondary outcomes include cardiovascular events and safety data. The trial is designed to inform whether early intensive LDL-C reduction translates into meaningful atherosclerotic change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

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.
* 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.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Tangdu Hospital, Air Force Medical University
  Xi’an, Shanxi, China Not yet recruiting

Study contacts

• Study coordinator: Xiaoyu Wang
• Email: wxy2cd@yeah.net
• Phone: 86+18384252874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.