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.
Study Type
OBSERVATIONAL
Enrollment
6,000
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.
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.
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.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGLipid 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)
Time frame: 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 average time for different treatment groups to reach the guideline-recommended lipid standards (\<1.4mmol/L) during the observation period.
Time frame: 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 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 frame: 12 months
Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events
Time frame: 12 months
Percentage change from baseline in LDL-C across treatment groups at different visit nodes
Time frame: 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
Inflammatory factors include IL-6, CRP/Hypersensitive CRP
Time frame: 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
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