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)
Major adverse cardiac and cerebrovascular events (MACCEs) — 24 months after the last patient's randomization A composite of death from any cause, myocardial infarction (MI), coronary revascularization, or stroke.
Trial sites (6)
Facility
City
Region
Status
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
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.
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