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

Last updated: April 10, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Disease

Atherosclerosis

Treatment

Placebo plus background lipid-modifying therapy

PCSK9 inhibitors and background lipid-modifying therapy

Standard lipid-modifying therapy

Clinical Study ID

NCT06863545
2025-0052
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be ≥ 18 years.

  2. Patients with at least one target lesion meet CCTA-detected plaque features of thefollowing:

  3. Degree of stenosis ≥ 50%

  4. At least 2 of the following high-risk plaque features: i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spottycalcium

  5. The target lesion is located at the proximal or mid segment of left anteriordescending artery, left circumflex artery or right coronary artery.

  6. Subject is able to confirm his/her understanding of the risks, benefits, andtreatment alternatives of receiving study-related treatment. He/she or his/herlegally authorized representative provides written informed consent prior to anystudy-related procedure.

Exclusion

Exclusion Criteria:

  1. Target lesions underwent or planned to revascularization.

  2. Patients with acute coronary syndrome.

  3. New York Heart Association class III or IV, or last known left ventricular ejectionfraction < 30%.

  4. Uncontrolled or recurrent ventricular tachycardia.

  5. Homozygous familial hypercholesterolemia.

  6. Active liver disease or hepatic dysfunction.

  7. Failed CCTA plaque analysis.

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

  9. Pregnant and/or lactating women.

  10. Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.

Study Design

Total Participants: 3596
Treatment Group(s): 3
Primary Treatment: Placebo plus background lipid-modifying therapy
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2033

Study Description

CCTA is an accurate, noninvasive alternative to invasive coronary angiography. CCTA can provide detailed information about the characteristics of coronary artery plaques, such as their composition, morphology, and distribution. Various CCTA-detected plaque characteristics indicative of plaque quantity and quality have been identified as high-risk features independently predicting clinical events, including the presence of positive remodeling, low attenuation plaque, spotty calcification, and napkin ring sign. Currently, the treatment for CCTA-detected high-risk plaque has been receiving increasing interest. The current study aimed to prove the efficacy of PCSK9 inhibitors in addition to the background LMT, as compared with placebo plus background LMT in patients with CCTA-detected high-risk plaques.

Hypothesis: PCSK9 inhibitors in addition to background LMT will show a superior event rate, compared with placebo plus background LMT, in terms of major adverse cardiac and cerebrovascular events (MACCEs) at 24 months after the last patient's randomization in patients with high-risk coronary plaques assessed by CT Angiography.

Connect with a study center

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou,
    China

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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