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临床试验/NCT05184530
NCT05184530已完成不适用

In-hospital Initiation of PCSK9 Inhibitor and Short-term Lipid Profile Alteration, as Well as In-hospital Mortality and Readmission Rate in Patients With Acute Myocardial Infarction

First Affiliated Hospital Xi'an Jiaotong University0 个研究点目标入组 7,556 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
7,556
主要终点
Readmission rate

研究概览

简要总结

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience.

A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College

排除标准

  • (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.

研究组 & 干预措施

PCSK9i Group

AMI patients with Statin plus PCSK9i therapy.

干预措施: Evolocumab 140 MG/ML (Drug)

Triple Group

AMI patients with Statin plus Ezetimibe plus PCSK9i therapy

干预措施: Evolocumab 140 MG/ML (Drug)

结局指标

主要结局

Readmission rate

时间窗: 1 YEAR

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

She JianQing

First Affiliated Hospital Xi'an Jiaotong University

First Affiliated Hospital Xi'an Jiaotong University

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