Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- The primary endpoint is the risk of MACE within 1 year of follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who received Evolocumab treatment at any time.
- •Patients who received Inclisiran treatment at any time.
研究组 & 干预措施
intervention group
patients were treated with alirocumab 75mg combined with statin ± ezetimibe
干预措施: alirocumab 75mg/2week (Drug)
control group
patients were treated with statin ± ezetimibe only
干预措施: statin ± ezetimibe (Drug)
结局指标
主要结局
The primary endpoint is the risk of MACE within 1 year of follow-up
时间窗: 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
次要结局
- Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up(1 month)
- Percentage reduction of LDL-C levels at 1-month follow-up from baseline(1 month)
研究者
Yun Dai Chen
professor
Chinese PLA General Hospital