Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT07208006

Very Early PCSK9 Inhibition for Acute Myocardial Infarction

Led by Shanghai Zhongshan Hospital · Updated on 2026-01-27

1518

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques. Coronary imaging techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiography-derived indices (QFR, RWS) can identify high-risk lesions, but the optimal management strategy is still debated. Early and intensive lipid-lowering therapy has been shown to stabilize atherosclerotic plaques. PCSK9 monoclonal antibodies, in combination with statins, provide rapid and profound LDL-cholesterol reduction and may enhance plaque stabilization beyond standard therapy. Small imaging studies suggest favorable effects of PCSK9 inhibitors on fibrous cap thickness and lipid burden, but their impact on clinical outcomes in AMI patients with multivessel disease remains uncertain. This study aims to evaluate whether very early in-hospital administration of a PCSK9 inhibitor, in addition to standard care, can reduce major adverse cardiovascular events (MACE) over 12 months compared with standard lipid-lowering therapy alone. The trial will also explore imaging-based markers of plaque vulnerability and functional indices as secondary endpoints, in order to better understand the mechanisms linking lipid lowering, plaque stabilization, and clinical outcomes.

CONDITIONS

Official Title

Very Early PCSK9 Inhibition for Acute Myocardial Infarction

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute myocardial infarction (AMI) within 30 days, confirmed STEMI or NSTEMI
  • Multivessel coronary artery disease with successful PCI of the culprit lesion in the infarct-related artery
  • At least one non-infarct artery with 50% or more diameter narrowing and vessel diameter of 2.5 mm or larger
  • Able to understand, provide written informed consent, follow medical therapy, and complete follow-up
Not Eligible

You will not qualify if you...

  • Cardiogenic shock or severe heart failure (Killip class IV)
  • Serum creatinine above 150 µmol/L or GFR less than 45 mL/min/1.73 m²
  • Known or suspected infective endocarditis or active systemic infection
  • Significant blood clotting problems or inability to tolerate long-term antiplatelet therapy
  • Pregnant or breastfeeding women, women planning pregnancy within 1 year, or unwilling to use effective contraception
  • Expected survival less than 1 year
  • Allergy to iodinated contrast media
  • Prior coronary artery bypass grafting (CABG)
  • Participation in another clinical trial within 3 months or ongoing without primary endpoint reached
  • Coronary angiography exclusions including non-infarct artery lesion with more than 90% narrowing and poor blood flow, complex disease requiring CABG, or unclear artery identification

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

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

W

Wei Gao, PhD

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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Very Early PCSK9 Inhibition for Acute Myocardial Infarction | DecenTrialz