Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)

• PCSK9 inhibitor (Drug): The patient used PCSK9 inhibitor (with or without statins ± Ezetimibe/Hybutimibe) in the early hospitalization, and patients continually prescribed or stopped PCSK9 inhibitors treatment during the follow-up visit, which depend on physician's clinical decision and patient preference. PCSK9 inhibitors include Evolocumab, Alirocumab, Tafolecimab, Recaticimab, and Inclisiran, among others.
• Statin+Ezetimibe/Hybutimibe compound (Drug): The patient used statins and Ezetimibe/Hybutimibe in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.
• Statin (Drug): The patient used statins in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.

Primary outcomes

• Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L) [3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge]: Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)

Secondary outcomes

• The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period. [3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge]: The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.
• The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups [12 months]: Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization
• Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events [12 months]
• Percentage change from baseline in LDL-C across treatment groups at different visit nodes [3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge]
• Change from baseline in inflammatory factors [3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge]: Inflammatory factors include IL-6, CRP/Hypersensitive CRP

Other outcomes

• The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE [At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge]
• The correlation between the duration of LDL-C within the target and MACE [12 months]
• The correlation between different baseline GRACE score levels (low, medium, high) and MACE [12 months]
• The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE [12 months]
• The correlation between different baseline age groups (≤ 45 years old or not) and MACE [12 months]
• Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI [12 months]: FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Age ≥ 18 years.
2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk.
3. Written informed consent must be obtained from eligible patients prior to study enrollment.
4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not taking statin in the last 4 weeks.

Exclusion Criteria:

1. Received PCSK9 inhibitor therapy within 3 months.
2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.
3. Patient has a history of renal or cardiac transplantation.
4. The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.

Patients judged by the investigator to be unsuitable for enrollment.

• Results publication: Yu YN, Wang Y, Tuo XD, Li ZX, Li DD, Chen YD. Rationale and design of the Early Initiation of Intensification Lipid-Lowering Treatment in Acute Coronary Syndrome (ELITE-ACS): a real-world study. J Geriatr Cardiol. 2026 Apr 28;23(4):246-256. doi: 10.26599/1671-5411.2026.04.003. PMID 42137728