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Clinical Trials in China / NCT06863545
Recruiting Not applicable

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

NCT06863545 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-04-22
Last updated
2026-02-06

Condition(s) studied

Coronary Artery DiseaseCT AngiographyPCSK9Cardiovascular Events

Investigational drug(s) / intervention(s)

PCSK9 inhibitors and background lipid-modifying therapyStandard lipid-modifying therapy

PCSK9 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.

Standard lipid-modifying therapy: Patients will receive standard LMT commonly used in clinical practice.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be ≥ 18 years. 2. Patients with at least one target lesion meet CCTA-detected plaque features of the following: 1. Degree of stenosis ≥ 50% or plaque burden ≥ 70% 2. At least 2 of the following high-risk plaque features: i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium 3. The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery. 4. 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 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 ejection fraction \< 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Zhejiang Provincial Hospital of Traditional Chinese Medicine Hangzhou Zhejiang Recruiting
Hangzhou Linping First People's Hospital Hangzhou China Recruiting
The Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China Recruiting
Zhejiang Hospital Hangzhou China Recruiting
Jinhua Central Hospital Jinhua China Recruiting
Seoul National University Hospital Seoul South Korea Not Yet Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06863545 on ClinicalTrials.gov ↗ ← All trials in China