Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06863545

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-06

3596

Participants Needed

6

Research Sites

414 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients with at least one target lesion showing CCTA-detected plaque with degree of stenosis 50% or more or plaque burden 70% or more
  • Target lesion has at least two high-risk plaque features: low-attenuation plaque, positive remodeling, napkin-ring sign, or spotty calcium
  • Target lesion located in proximal or mid segment of left anterior descending artery, left circumflex artery, or right coronary artery
  • Able to understand study risks, benefits, and alternatives and provide written informed consent
Not Eligible

You will not qualify if you...

  • Target lesions that have undergone or are planned for revascularization
  • Patients with acute coronary syndrome
  • New York Heart Association class III or IV heart failure or left ventricular ejection fraction less than 30%
  • Uncontrolled or recurrent ventricular tachycardia
  • Homozygous familial hypercholesterolemia
  • Active liver disease or hepatic dysfunction
  • Failed coronary CT angiography plaque analysis
  • Non-cardiac conditions with life expectancy less than 2 years
  • Pregnant or breastfeeding women
  • Known allergy or contraindication to statins or PCSK9 inhibitors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

2

Hangzhou Linping First People's Hospital

Hangzhou, China

Actively Recruiting

3

The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Actively Recruiting

4

Zhejiang Hospital

Hangzhou, China

Actively Recruiting

5

Jinhua Central Hospital

Jinhua, China

Actively Recruiting

6

Seoul National University Hospital

Seoul, South Korea

Not Yet Recruiting

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Research Team

X

Xinyang Hu

CONTACT

J

Jian'an Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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