Clinical trial
Effects of Intensive Lipid-lowering on Coronary Atherosclerotic Plaque Phenotype and Major Adverse Cardiovascular Events in Adults With Low to Intermediate 10-year ASCVD Risk: a Prospective, Randomized, Open-label, Blinded Endpoint Analysis(PROBE)
Name
2021-CXGC03-3
Description
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.
Trial arms
Trial start
2022-10-10
Estimated PCD
2023-12-01
Trial end
2025-12-01
Status
Recruiting
Treatment
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.
Arms:
intensive lipid-lowering group
Other names:
Lower goal for reducing LDL-C
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.
Arms:
moderate-intensity lipid-lowering group
Other names:
Standard goal for reducing LDL-C
Size
2900
Primary endpoint
Major Adverse Cardiovascular Events (MACE)
Within 3 years after the enrollment
Eligibility criteria
Inclusion Criteria:
1. Age 40-75 years
2. Low to Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk by using pooled cohort equations (PCE).
3. Coronary CT angiography shows atherosclerotic plaque 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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'blinded endpoint', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2900, 'type': 'ESTIMATED'}}
Updated at
2023-04-27
1 organization
2 products
1 indication
Organization
Chinese Academy of Medical SciencesIndication
Coronary Artery Disease Progression