About this trial
The objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (MACE) in Chinese ACS patients. The main question it aims to answer is:
whether early initiation PCKS9i in hospital could reduce recent cardiovascular event risk in Chinese ACS patients in real-world setting.
Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with Acute Coronary Syndrome (ACS) upon hospital admission.
Patients aged 18 years or older.
Patients who received Alirocumab 75 mg in combination with statin therapy ± Ezetimibe as the intervention group, and those treated exclusively with statin therapy ± Ezetimibe as the control group, either during hospitalization or at discharge.
Patients with at least one follow-up record.
Disqualifiers
Patients who received Evolocumab treatment at any time.
Patients who received Inclisiran treatment at any time.
Trial population
Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit. Patients prescribed with evolocumab at any time will be excluded.
Trial design
Cohort
Retrospective
Treatments tested in this trial
alirocumab 75mg/2week
Drugpatients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference
statin ± ezetimibe
Drugpatients will be censored at initiation of alirocumab during the follow up visit
Treatment groups
Trial outcomes
Primary outcomes
The primary endpoint is the risk of MACE within 1 year of follow-up
MACE was defined as the composite of non-fatal myocardial infarction, non-fatal ischemic stroke, all-cause mortality, or any coronary revascularization. Coronary revascularization was limited to procedures occurring at least two weeks after the index date, including PCI and CABG
Secondary outcomes
Percentage reduction of LDL-C levels at 1-month follow-up from baseline
Percentage reduction of LDL-C levels at 1-month follow-up from baseline
Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up
Proportion of patient who achieved LDL-C goal (\<1.4mmol/L) at 1-month follow-up
Other outcomes
Association between ACS pathway optimization participation and MACE within 1 year follow-up
Association between ACS pathway optimization participation and MACE within 1 year follow-up
Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up
Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up
Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)
Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)
LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)
LDL-C goal attainment rate (\<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)
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