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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Completed

CT.gov ID

NCT05184530

Collaborator

(none)

7,556

Enrollment

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Drug: Evolocumab 140 MG/ML

Study Design

Study Type:

Observational

Actual Enrollment :

7556 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Statin Group AMI patients with Statin therapy.
Ezetimibe Group AMI patients with Statin plus Ezetimibe therapy.
PCSK9i Group AMI patients with Statin plus PCSK9i therapy.	Drug: Evolocumab 140 MG/ML 140 mg per two weeks, subcutaneous injection
Triple Group AMI patients with Statin plus Ezetimibe plus PCSK9i therapy	Drug: Evolocumab 140 MG/ML 140 mg per two weeks, subcutaneous injection

Outcome Measures

Primary Outcome Measures

Readmission rate [1 YEAR]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

She JianQing, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05184530

Other Study ID Numbers:

82100477-1

First Posted:

Jan 11, 2022

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Coronary Disease

Infarction

Evolocumab

Study Results

No Results Posted as of Jan 11, 2022