Rationale and design of the Early Initiation of Intensification Lipid-Lowering Treatment in Acute Coronary Syndrome (ELITE-ACS): a real-world study.

OBJECTIVE: To investigate the effects of early in-hospital intensive lipid-lowering therapy (LLT) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors on lipid dynamics and clinical outcomes in Chinese acute coronary syndrome (ACS) patients, providing robust real-world evidence for its long-term benefits and optimal implementation timing to address the evidence gap in optimal lipid management for secondary prevention. METHODS & RESULTS: This multicenter prospective real-world study (http://www.clinicaltrials.gov, NCT number: NCT06738758), which building upon the ELEGANT pilot registry (ChiCTR2200065861), will enroll 6000 consecutively hospitalized ACS patients with uncontrolled dyslipidemia across more than 30 Chinese centers. Participants are enrolled based on recommended stratified proportions [(1) diagnostic categories: ST-segment elevation myocardial infarction : non-ST-segment elevation myocardial infarction : intermediate-high-risk unstable angina = 1:1:3; and (2) lipid-lowering strategies: PCSK9 inhibitor ± statin : statin+ezetimibe/hybutimibe : statin = 2:1:2). Treatment assignment reflects real-world clinical decisions guided by low-density lipoprotein cholesterol levels and patient preference. Twelve-month follow-up assessments were conducted at predefined intervals: baseline hospitalization, discharge, and 1, 3, 6, 12 months post-discharge. Primary endpoints were the goal attainment (low-density lipoprotein cholesterol < 1.4 mmol/L) rates across treatment arms. Key secondary endpoints were the major adverse cardiovascular events (including myocardial infarction, ischemic stroke, cardiovascular mortality, coronary revascularization) and all-cause death, and other secondary endpoints encompassed time-to-lipid-goal, longitudinal changes in lipids profiles and inflammatory biomarkers, and perivascular fat attenuation index evolution quantified by coronary computed tomographic angiography. Propensity score matching and inverse probability treatment weighting will address confounding bias. CONCLUSIONS: This study will pioneer evidence clarifying the optimal therapeutic window and clinical benefits of in-hospital intensive LLT for Chinese ACS patients. By establishing the first Chinese population-derived evidence for the "early intensive and rapid target attainment" strategy, our findings may challenge stepwise LLT paradigms. These results may guide international guideline updates for high-risk ACS populations, particularly in East Asian cohorts with distinct lipid profiles.