Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Led by Shanghai Tong Ren Hospital · Updated on 2025-05-21

20

Participants Needed

2

Research Sites

233 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.

CONDITIONS

Official Title

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 80 years
  • Successful percutaneous coronary intervention with drug-eluting stent for acute myocardial infarction
  • Left anterior descending artery is the only affected vessel
  • Able to understand study requirements and provide informed consent before procedure
Not Eligible

You will not qualify if you...

  • Female of childbearing potential unless recent pregnancy test is negative and no plan to become pregnant during study
  • Known allergy or contraindication to study medications
  • Planning to have revascularization within six months
  • Previous revascularization procedure
  • Life expectancy less than one year
  • Active cancer
  • Severe liver dysfunction (ALT >5 times upper limit of normal) or severe kidney dysfunction (eGFR <15 ml/min/1.73m2)
  • Other conditions judged unsuitable by investigators

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Tongren Hospital, Shanghai

Shanghai, Shanghai Municipality, China

Actively Recruiting

2

Shanghai tenth people's hospital

Shanghai, China

Actively Recruiting

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Research Team

L

Lei Hou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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