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

Official title

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

Overview

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.

Interventions

• Drug PCSK9 inhibitor
  The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months
• Drug Statin+ezetimibe
  The patient used statins and ezetimibe within 24 hours before or after PCI, and then once a day for 12 months
• Behavioral Blood lipid levels meet the recommended guidelines
  Early use of intensified lipid-lowering therapy during hospitalization led to a rapid decrease in blood lipids and met the recommended guidelines.
• Behavioral Blood lipid levels don't meet the recommended guidelines
  The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids

Primary outcome measures

• Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up. [Time frame: 12 months]
• Changes in pericoronary artery fat attenuation index (FAI) measured by CCTA for non-culprit lesions at baseline and 12 months of follow-up [Time frame: 12 months]

Secondary outcome measures (4)

• Progress of target lesion plaques [Time frame: 12 months]
• The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups [Time frame: 12 months]
• The proportion of LDLC at each visit node that meets the recommended guidelines and the changes compared to baseline [Time frame: 1week；1months；3 months； 6 months; 9 months; 12 months]
• Changes in inflammatory factors (interleukin 6, C reaction protein) at each visit node compared to baseline [Time frame: 1week；1months；3 months； 6 months; 9 months; 12 months]

Eligibility criteria

Inclusion criteria

• 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.
• Willing to undergo 1-year follow-up.

Exclusion criteria

• 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;
• Received any PCSK9 inhibitor treatment within the previous 3 months;
• Pregnant or nursing women or women planning pregnancy;
• The researcher determined that it was not suitable for inclusion in the group.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Chinese PLA General Hospital — Beijing
• Chinese PLA General Hospital [ — Beijing

Identifiers

NCT: NCT06854523 · ASCVD2030-6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗