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

NCT05184530 | Completed

• 1 other identifier: 82100477-1
• Study Type: observational
• Target: 7,556
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Readmission rate

  1 YEAR

Study Arms (4)

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

Triple Group

AMI patients with Statin plus Ezetimibe plus PCSK9i therapy

Drug: Evolocumab 140 MG/ML

Interventions

Evolocumab 140 MG/ML DRUG

140 mg per two weeks, subcutaneous injection

PCSK9i Group; Triple Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

7556 consecutive patients admitted to the cardiology department of the First Affiliated Hospital of Xi'an Jiaotong University for AMI between January 2016 and December 2020 were enrolled.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (1)

• 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.

  PMID: 36280861 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Affiliated Hospital Xi'an Jiaotong University

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 11, 2022
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01