Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients
NCT Number: NCT06567418
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Coronary Syndrome
Interventions: DRUG: alirocumab 75mg/2week|DRUG: statin ± ezetimibe
Sponsor: Yun Dai Chen
Collaborators: Sanofi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-31
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
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.

Primary Outcome Measures: 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, 12 months
Secondary Outcome Measures: 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, 1 month|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, 1 month
Other Outcome Measures: 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, 12 months|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, 1 month|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), 3 months, 6 months|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), 3 months, 6 months