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NCT Number: NCT06854523

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCSK9 inhibitor

Drug

The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months

Statin+ezetimibe

Drug

The patient used statins and ezetimibe within 24 hours before or after PCI, and then once a day for 12 months

Blood lipid levels meet the recommended guidelines

Behavioral

Early use of intensified lipid-lowering therapy during hospitalization led to a rapid decrease in blood lipids and met the recommended guidelines.

Blood lipid levels don't meet the recommended guidelines

Behavioral

The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids

Primary outcomes

  1. 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

    IPA is a quantitative analysis tool based on OCT technology to evaluate plaque stability.

  2. 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

    FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.

Secondary outcomes

  1. Progress of target lesion plaques

    Time frame: 12 months

    To assess plaque progression, OCT evaluation will include fiber cap thickness, lipid core amplitude, minimum lumen area, and minimum lumen diameter. CCTA evaluation will include CAD-RADS grade , plaque volume, plaque properties, calcification score, epicardial fat volume and plaque attenuation.

    Notes: CAD-RADS indicates Coronary Artery Disease-Reporting and Data System, which range from 0 to 5. The higher CAD-RADS grade, the more severe of the coronary stenosis.

  2. The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups

    Time frame: 12 months

    MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dandan Li

CONTACT

[email protected]

8613810545564

Sponsors and collaborators

Lead sponsor

Yun Dai Chen

Other

Registry information

Official study title

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

Acronym: ACCESS-AMI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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