In-hospital Initiation of PCSK9 Inhibitor in Patients Wit... | NCT05184530

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

NCT05184530

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

7,556Actual

Phase

Not provided

Conditions

Coronary Disease

Interventions

Evolocumab 140 MG/ML

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2021Actual

First Submitted Date

Jan 5, 2022

First Submission Date that Met QC Criteria

Jan 7, 2022

First Posted Date

Jan 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2022

Last Update Posted Date

Jan 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,556Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab 140 MG/ML	Drug	140 mg per two weeks, subcutaneous injection	PCSK9i Group Triple Group

Measure	Description	Time Frame
Readmission rate		1 YEAR

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36280861	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases