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Clinical Trials in China / NCT06936111
Recruiting Observational

REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease

NCT06936111 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Observational
Started
2025-07-01
Last updated
2026-02-03

Condition(s) studied

Coronary Heart Disease (CHD)

Investigational drug(s) / intervention(s)

Assessment of residual cholesterol and inflammatory risk factors

Assessment of residual cholesterol and inflammatory risk factors: The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)

Study summary

Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with CAD and PCI was successfully performed. * Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges). * 18 to 75 years old. * Written informed consent. Exclusion Criteria: * Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset. * Known familial hypercholesterolemia. * Critical conditions (e.g., cardiogenic shock, acute heart failure). * Severe renal insufficiency (eGFR \< 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal). * Severe underlying diseases (such as end-stage malignancies), life expectancy \< 1 year. * Allergic to lipid-lowering medications. * Pregnant, or trying to become pregnant, and breastfeeding women. * Other conditions deemed unsuitable for inclusion by the researcher.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Zhongshan Hospital Shanghai China Recruiting

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Official registry record

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.

View NCT06936111 on ClinicalTrials.gov ↗ ← All trials in China