RecruitingNot ApplicableNCT06863545

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

3,596 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease Cardiovascular Events CT Angiography PCSK9

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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:
i. 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.

Exclusion Criteria10

Target lesions underwent or planned to revascularization.
Patients with acute coronary syndrome.
New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.
Uncontrolled or recurrent ventricular tachycardia.
Homozygous familial hypercholesterolemia.
Active liver disease or hepatic dysfunction.
Failed CCTA plaque analysis.
Non-cardiac co-morbid conditions with life expectancy \< 2 years.
Pregnant and/or lactating women.
Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPCSK9 inhibitors and background lipid-modifying therapy

Patients will receive subcutaneous injections of PCSK9 inhibitors and oral administration of background LMT (including statins and/or cholesterol absorption inhibitors) for the first 12 months after randomization, with PCSK9 inhibitors administered every 2 weeks. After the first 12 months, patients will discontinue the PCSK9 inhibitors but continue background LMT for the remainder of the trial.

DRUGStandard lipid-modifying therapy

Patients will receive standard LMT commonly used in clinical practice.