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

NCT ID: NCT05184530

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7556 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-12-31

Brief Summary

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

Conditions

Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Statin Group

AMI patients with Statin therapy.

No interventions assigned to this group

Ezetimibe Group

AMI patients with Statin plus Ezetimibe therapy.

No interventions assigned to this group

PCSK9i Group

AMI patients with Statin plus PCSK9i therapy.

Evolocumab 140 MG/ML

Intervention Type: DRUG

140 mg per two weeks, subcutaneous injection

Triple Group

AMI patients with Statin plus Ezetimibe plus PCSK9i therapy

Evolocumab 140 MG/ML

Intervention Type: DRUG

140 mg per two weeks, subcutaneous injection

Interventions

Evolocumab 140 MG/ML

140 mg per two weeks, subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

She JianQing

First Affiliated Hospital Xi'an Jiaotong University

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Lou B, Liu H, Luo Y, Jiang GT, Wu H, Wang C, Wu Y, Zhou B, Yuan Z, She J, Liu J. In-hospital initiation of PCSK9 inhibitor and short-term lipid control in patients with acute myocardial infarction. Lipids Health Dis. 2022 Oct 24;21(1):105. doi: 10.1186/s12944-022-01724-9.

Reference Type: DERIVED

PMID: 36280861 (View on PubMed)

Other Identifiers

82100477-1

Identifier Type: -

Identifier Source: org_study_id