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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a type of medication called PCSK9 inhibitors to see if they can help lower cholesterol levels even more in patients who already have treatment for high cholesterol. The goal is to find out if adding these medications can improve health outcomes for patients who have specific high-risk plaques in their coronary arteries, which were detected using a special imaging test called a CT angiography. The trial is currently looking for participants aged 18 and older who have at least one significant plaque in their arteries that meets certain criteria.

To be eligible for this study, participants need to have a significant blockage in their arteries (at least 50%) and at least two specific features that suggest the plaque is high-risk. Participants should also be able to understand the risks and benefits of the treatment and give their consent to join the study. Those with serious heart-related issues, recent heart attacks, or other significant health problems may not qualify. If chosen to participate, individuals will receive either the PCSK9 inhibitor along with their regular treatment or just the standard treatment, and researchers will monitor their health over time to evaluate the effects.

Gender

ALL

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%
• 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.