Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction (ACCESS-AMI)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYun Dai Chen

About this trial

This study is planned to start on January 2024.

The goal of this clinical trial is to learn whether the perioperative administration (within 24 hours before or after primary PCI) of PCSK9 inhibitors can ameliorate plaque progression and adverse outcomes in patients with acute myocardial infarction (AMI). The main questions it aims to answer are:

Can perioperative PCSK9 inhibition improve the plaque stability and inflammation of perivascular adipose tissue (index of plaque attenuation(IPA )and perivascular fat attenuation index(FAI)) of non-target lesions? Researchers will compare PCSK9 inhibitors with statin plus ezetimibe therapy to evaluate the potential of PCSK9 inhibitors in mitigating the progression of non-target lesion plaques and reducing adverse cardiovascular events in patients with AMI.

Participants will:

Take PCSK9 inhibitors every two weeks or daily statin plus ezetimibe therapy. Conduct a follow-up examination with optical coherence tomography (OCT) or coronary computed tomography angiography (CTA) after 12 months.

Record the occurrence of major adverse cardiovascular events.

Eligibility criteria

Qualifiers

Age ≥18 years old.

Admitted to hospital for acute myocardial infarction (STEMI, NSTEMI) and successfully underwent PCI of the infarct vessel.

Coronary angiography revealed two non-infarct-related arteries with non-blocking lesions (diameter stenosis of 40-70%).

Able to sign informed consent.

Disqualifiers

Left main artery disease or severe coronary artery calcification;

Hemodynamic instability or uncontrolled arrhythmia;

History of coronary artery bypass;

severe renal insufficiency, active liver disease or liver insufficiency, hematological disease, metabolic or endocrine dysfunction, systemic infection, active malignant tumor and other potentially life-threatening diseases, or the expected survival time is < 1 year;

Trial design

Treatments tested in this trial

  • PCSK9 inhibitor
  • Statin+ezetimibe
  • Blood lipid levels meet the recommended guidelines
  • Blood lipid levels don't meet the recommended guidelines

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yun Dai Chen

Lead sponsor

Chinese PLA General Hospital

Sponsor institution