Using PCSK9 inhibitors to lower cholesterol in patients with high-risk coronary plaques

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

This study tests if adding a new cholesterol-lowering medication to standard treatment can help people with high-risk heart plaques avoid serious heart and brain problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3596 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 6 sites (Hangzhou, Zhejiang and 5 other locations)
• Trial ID: NCT06863545 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of PCSK9 inhibitors in addition to standard lipid-modifying therapy compared to a placebo in patients with high-risk coronary plaques identified through CT angiography. The research focuses on patients who exhibit specific high-risk plaque features that are known to predict adverse cardiovascular events. By assessing clinical outcomes over a 24-month period, the study aims to determine if the addition of PCSK9 inhibitors can significantly reduce major adverse cardiac and cerebrovascular events. The study utilizes a randomized, controlled design to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with significant coronary artery disease and specific high-risk plaque characteristics detected by CT angiography.

Not a fit: Patients with acute coronary syndrome or those who have undergone recent revascularization procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cardiovascular outcomes for patients with high-risk coronary plaques.

How similar studies have performed: Other studies have shown promising results with PCSK9 inhibitors in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang and 5 other locations

• Zhejiang Provincial Hospital of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (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)

Study contacts

• Principal investigator: Xinyang Hu — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Xinyang Hu

Conditions Coronary Artery Disease; CT Angiography; PCSK9; Cardiovascular Events; PCSK9 inhibitors; Lipid-lowering therapy; High-Risk Coronary Plaques; Coronary CT angiography