Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular Events in Intermediate 10-year ASCVD Risk Population

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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 (luminal stenosis<50%) 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Criteria

Inclusion Criteria:

1. Age 20-75 years

2. Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk population in China-PAR model

3. Coronary CT angiography shows non-calcified plaque-dominated lesions in the main coronary vessels (>2mm diameter) with luminal stenosis <50%

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

2. Myocardial infarction, coronary revascularization, or severe/unstable angina 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. Uncontrollable 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