The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events.
The primary research question is whether early initiation of PCSK9 inhibitor therapy during hospitalization for ACS patients in a real-world Chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events.
Researchers will compare three lipid-lowering strategies: PCSK9 inhibitor therapy (with or without statins ± Ezetimibe/Hybutimibe), statin plus Ezetimibe/Hybutimibe therapy, and statin monotherapy, to assess the potential of PCSK9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in ACS patients.
Participants will:
Receive PCSK9 inhibitor therapy (with or without daily statins ± Ezetimibe/Hybutimibe) every two weeks, or daily statin plus Ezetimibe/Hybutimibe therapy, or daily statin monotherapy.
Undergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge.
Record the occurrence of major adverse cardiovascular events.
Age ≥ 18 years.
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.
Written informed consent must be obtained from eligible patients prior to study enrollment.
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.
Received PCSK9 inhibitor therapy within 3 months.
Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.
Patient has a history of renal or cardiac transplantation.
The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.
Patients hospitalized for acute coronary syndrome (ACS). ACS is defined as STEMI, NSTEMI, and UA, where UA must be classified as high-risk in the GRACE score.
Cohort
Prospective
PCSK9 inhibitor
DrugThe 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
DrugThe 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
DrugThe 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.
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
Lipid attainment rate at each visit node during the observation period (\<1.4 mmol/L)
The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.
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
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
Percentage change from baseline in LDL-C across treatment groups at different visit nodes
The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE
The correlation between the duration of LDL-C within the target and MACE
The correlation between different baseline GRACE score levels (low, medium, high) and MACE
The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE
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Yun Dai Chen
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
