Chinese Academy of Medical Sciences, Fuwai Hospital
Phase
Not applicable
Started
2022-10-10
Last updated
2026-07-20
Condition(s) studied
Coronary Artery Disease Progression
Investigational drug(s) / intervention(s)
Intensive lipid-lowering controlModerate-intensity lipid-lowering control
Intensive lipid-lowering control: The initial recommended therapy is 10-20mg atorvastatin plus Ezetimibe, and the type and dosage of drugs can be adjusted according to the situation.
Moderate-intensity lipid-lowering control: The initial recommended therapy is 10-20mg atorvastatin, and the type and dosage of drugs can be adjusted according to the situation.
Study summary
Current guidelines recommend moderate-intensity lipid-lowering therapy (goal for LDL-C \<2.6 mmol/L or 30%-50% reduction from baseline) for patients with intermediate 10-year ASCVD risk. In these patients, early coronary atherosclerotic plaques detected by coronary CT angiography are common, but further interventions are lacking. This study aims to analyze whether intensive lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L or ≥50% reduction from baseline) could delay the progression of coronary atherosclerotic lesions and reduce the adverse cardiovascular events in these target patients.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 40-75 years
2. Low to Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk using pooled cohort equations (PCE).
3. Coronary CT angiography shows atherosclerotic plaque in the main coronary vessels (\>2mm diameter) with luminal stenosis \<70%
Exclusion Criteria:
1. Combination with serious cardiovascular diseases, including
1. Heart failure (ejection fraction \<30%)
2. Arrhythmias (persistent atrial flutter/atrial fibrillation, second-degree or third-degree atrioventricular block)
3. Hemodynamically important valvular disease
4. Hemodynamically important congenital heart disease
5. Stroke
2. Myocardial infarction, coronary revascularization, or severe/unstable angina before or within 1 month of screening
3. Active liver disease or hepatic dysfunction (defined as alanine aminotransferase or aspartate aminotransferase\> 3 times the upper limit of normal)
4. Unexplained creatine phosphokinase\> 6 times the upper limit of normal
5. Nephrotic syndrome
6. Diabetes mellitus
7. Uncontrollable hypertension
8. Uncontrollable hypothyroidism
9. Hypersensitivity to statins
10. Any planned surgical procedure for the treatment of atherosclerosis
11. Gastrointestinal diseases affecting drug absorption or history of gastrointestinal surgery
12. Survival-limiting diseases
13. Concurrent long-term immunosuppressive therapy
14. Participation in another clinical trial concurrently or within 30 days before screening
15. Pregnant or breastfeeding
16. Other unsuitable situations deemed by physicians
Primary outcome measure(s)
Major Adverse Cardiovascular Events (MACE) — Within 3 years after the enrollment Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital
Beijing
Beijing Municipality
More Chinese Academy of Medical Sciences, Fuwai Hospital trials in China
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.
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