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NCT06863545Recruiting

Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
3596 (estimated)
First submitted
3 Mar 2025
Start date
22 Apr 2025
Primary completion date
30 Apr 2030
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT06863545

What you commit to

  • Study type: Interventional
  • Planned participants: 3596
  • From 22 Apr 2025 to the primary completion date, 30 Apr 2030
  • 6 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with acute coronary syndrome.
  • Active liver disease or hepatic dysfunction.
  • Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.

Lab values

  • New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.

Age

  • Non-cardiac co-morbid conditions with life expectancy \< 2 years.

Other

  • Target lesions underwent or planned to revascularization.
  • Uncontrolled or recurrent ventricular tachycardia.
  • Homozygous familial hypercholesterolemia.
  • Failed CCTA plaque analysis.
  • Pregnant and/or lactating women.

Who the study is looking for

  • Subject must be ≥ 18 years.
  • Patients with at least one target lesion meet CCTA-detected plaque features of the following:
    • Degree of stenosis ≥ 50% or plaque burden ≥ 70%
    • At least 2 of the following high-risk plaque features:
    • Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
  • The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
  • Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Hangzhou Linping First People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Zhejiang Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The Second Affiliated Hospital,School of Medicine,Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Jinhua Central Hospital
Coordinator of this site? Confirm its status
JinhuaChinaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.