In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT05184530
Status
Completed

Conditions

  • Coronary Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jan 31, 2016
Status verified
Jan 2022
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
7,556 participants (actual)

Arms

  • Arm: Statin Group
    AMI patients with Statin therapy.
  • Arm: Ezetimibe Group
    AMI patients with Statin plus Ezetimibe therapy.
  • Arm: PCSK9i Group
    AMI patients with Statin plus PCSK9i therapy.
  • Arm: Triple Group
    AMI patients with Statin plus Ezetimibe plus PCSK9i therapy

Primary Outcome Measure

Readmission rate [ Time Frame: 1 YEAR ]

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