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

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Xi'an Jiaotong University

Status

Completed

Conditions

Coronary Disease

Treatments

Drug: Evolocumab 140 MG/ML

Study type

Observational

Funder types

Other

Identifiers

NCT05184530
82100477-1

Details and patient eligibility

About

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

Enrollment

7,556 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • (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.

Trial design

7,556 participants in 4 patient groups

Statin Group
Description:
AMI patients with Statin therapy.
Ezetimibe Group
Description:
AMI patients with Statin plus Ezetimibe therapy.
PCSK9i Group
Description:
AMI patients with Statin plus PCSK9i therapy.
Treatment:
Drug: Evolocumab 140 MG/ML
Triple Group
Description:
AMI patients with Statin plus Ezetimibe plus PCSK9i therapy
Treatment:
Drug: Evolocumab 140 MG/ML

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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