Acute Coronary Syndrome
Conditions
Brief 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.
Interventions
DRUGalirocumab 75mg/2week
patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference
DRUGstatin ± ezetimibe
patients will be censored at initiation of alirocumab during the follow up visit
Sponsors
Sanofi
Yun Dai Chen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients who received Evolocumab treatment at any time. * Patients who received Inclisiran treatment at any time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the risk of MACE within 1 year of follow-up | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction of LDL-C levels at 1-month follow-up from baseline | 1 month | 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 | 1 month | Proportion of patient who achieved LDL-C goal (\<1.4mmol/L) at 1-month follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association between ACS pathway optimization participation and MACE within 1 year follow-up | 12 months | Association between ACS pathway optimization participation and MACE within 1 year follow-up |
| 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 | LDL-C goal attainment rate (\<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test) |
| Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up | 1 month | 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) | 3 months, 6 months | Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test) |
Countries
China
Contacts
Primary ContactDandan Li, Dr.
Outcome results
None listed