Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.
Lipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to \<1.4 mmol/L with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.
Against these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels \<0.8 mmol/L in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol/L.
Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
Patients with ASCVD at extremely high risk
Patients who are able to complete the follow-up and compliant with the allocated treatment
PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)
Age less than 18 years;
Unable to give informed consent or currently participating in other trials;
Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;
Concurrent medical condition with a life expectancy of less than 3 years;
Parallel
Intensive LDL-C control
Other interventionBy Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level \< 3.0 mmol/L, it is recommended to start lipid control by statin + PCSK9i; for LDL-C level ≥ 3.0 mmol/L, statin + ezetimibe + PCSK9i
Conventional LDL-C control
Other interventionBy Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level \< 3.0 mmol/L, it is recommended to start lipid control by statin alone or statin + ezetimibe; for LDL-C level ≥ 3.0 mmol/L, statin + PCSK9i
Major Adverse Cardiovascular and Cerebrovascular Events
MACCE, a composite of cardiovascular death, stroke, myocardial infarction, and any revascularization.
Patient-oriented composite endpoint
PoCE, a composite of all-cause death, stroke, myocardial infarction, revascularization, is the first major secondary outcome.
Device-oriented Composite Endpoint
DoCE, a composite of cardiovascular death, target vessel myocardial infarction, clinically and physiologically-indicated target lesion revascularization, is the second major secondary outcome.
Composite of all-cause death, stroke, and myocardial infarction
The composite of all-cause death, stroke, and myocardial infarction is the third major secondary outcome.
All-cause death
All-cause death is considered as other secondary endpoint
EuroQol-5D-5L
EuroQol-5D-5L is considered as exploratory endpoint
Everyday Cognition Questionnaire
Everyday Cognition Questionnaire is considered as exploratory endpoint
Pharmacological costs
Pharmacological costs is considered as exploratory endpoint
All adverse events
All adverse events is defined by CTCAE V5.0, considered as safety endpoint
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