This is a multicenter, open-label, parallel-group, randomized trial to determine if intensive lipid-lowering therapy (goal for LDL-C \<1.0 mmol/L and ≥50% reduction frome baseline) could delay progression of coronary atherosclerotic obstructive leisions compared with guideline recommended lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L and ≥50% reduction frome baseline) among participants between 18-60 years old with non-invasively managed chronic coronary syndrome (at least one lesion with a 50%-70% stenosis).
None
Left main coronary artery disease or severe three-vessel disease;
Ultra-high-risk ASCVD patients: ≥2 severe ASCVD events or 1 severe ASCVD event with ≥2 high-risk factors;
Use of PCSK9 inhibitors or ezetimibe within 8 weeks prior to study enrollment;
The baseline LDL-C was relatively high (LDL-C≥2.6 mmol/L in those taking statins and ≥4.9 mmol/L in those not taking statins).
Parallel
Intensive lipid-lowering strategy
DrugThe initial recommended therapy is 20mg atorvastatin/10mg rosuvastatin plus Ezetimibe or PCSK9i, and the type and dosage of drugs can be adjusted according to the situation. If the target LDL-C level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Standard lipid-lowering strategy
DrugThe initial recommended therapy is 20mg atorvastatin/10mg rosuvastatin, and the type and dosage of drugs can be adjusted according to the situation. If the target L-DLC level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
The composite events of atherosclerotic plaque progression
A composite end-point comprised of plaque progression, nonfatal myocardial infarction, death, or unstable angina driven rehospitalization or revascularization. Plaque progression is defined as an anual progression of PAV measured by CCTA more than 1%. PAV = (total plaque volume/vessel volume) \*100%.
Major adverse cardiac events
Composite of nonfatal myocardial infarction, death, or unstable angina driven rehospitalization or revascularization.
Plaque progression event
The proportion of annual change in PAV \>1%
Agatston score changes of coronary artery and aortic valve
Evaluating intensive group compared to standard group in Agatston score changes of coronary artery and aortic valve evaluated by CCTA
Percentage change in total coronary atheroma volume
Evaluating intensive group compared to standard group in total atheroma volume change evaluated by CCTA. PAV = (total plaque volume/vessel volume) \*100%.
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Liu yong
Lead sponsor
Guangdong Provincial People's Hospital
Sponsor institution
