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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | patients were treated with alirocumab 75mg combined with statin ± ezetimibe |
| |
| control group | patients were treated with statin ± ezetimibe only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab 75mg/2week | Drug | patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Li, Dr. | Contact | +86 13810545564 | lidandan5564@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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| statin ± ezetimibe | Drug | patients will be censored at initiation of alirocumab during the follow up visit |
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Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up
| 1 month |
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 |