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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05184530
Other study ID # 82100477-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2021

Study information

Verified date January 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 7556
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Evolocumab 140 MG/ML
140 mg per two weeks, subcutaneous injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission rate 1 YEAR
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