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Study identifier: NCT06863545 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingFLAVOUR IV

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

Condition: Coronary Artery Disease · CT Angiography · PCSK9  ·  Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

PhaseNA
Planned participants3596
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where6 locations · 2 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xinyang Hu  ·  +86 0571 87784808  ·  hxy0507@126.com

Jian'an Wang  ·  +86 0571 87784808  ·  wangjianan111@zju.edu.cn

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (6)

Zhejiang Provincial Hospital of Traditional Chinese MedicineHangzhou, Zhejiang, ChinaRecruiting
Hangzhou Linping First People's HospitalHangzhou, ChinaRecruiting
The Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaRecruiting
Zhejiang HospitalHangzhou, ChinaRecruiting
Jinhua Central HospitalJinhua, ChinaRecruiting
Seoul National University HospitalSeoul, South KoreaNot Yet Recruiting

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

HangzhouJinhuaSeoul

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