Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06364124

Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Led by Beijing Luhe Hospital · Updated on 2024-05-22

84

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.

CONDITIONS

Official Title

Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients treated at Beijing Luhe Hospital with direct PCI for STEMI
  • Chest pain lasting at least 30 minutes with ST-segment elevation ≥ 0.1 mV in two adjacent leads on ECG
  • Symptoms started within the past 24 hours
  • Age between 18 and 80 years
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Hemodynamically unstable or Killip grade 2 or higher
  • Severe kidney failure with glomerular filtration rate below 30 ml/min/1.73m²
  • Active liver disease or liver dysfunction with AST or ALT more than three times the upper limit
  • Allergy to any study medication
  • Previous or planned use of PCSK9 inhibitors
  • Suspected stress cardiomyopathy or acute pericarditis
  • Malignant tumors requiring treatment or other serious systemic diseases
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing luhe hospital

Beijing, China

Actively Recruiting

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Research Team

R

rui yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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