NCT06863545 Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
| NCT ID | NCT06863545 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,596 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,596 participants in total. It began in 2025-04-22 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Xinyang Hu
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT06863545 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06863545 currently recruiting?
Yes, NCT06863545 is actively recruiting participants. Contact the research team at hxy0507@126.com for enrollment information.
Where is the NCT06863545 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Hangzhou, China, Hangzhou, China and 2 additional locations.
Who is sponsoring the NCT06863545 clinical trial?
NCT06863545 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Xinyang Hu at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 3,596 participants.