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

February 25, 2025 updated by: Yun Dai Chen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital [
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old.
  2. Admitted to hospital for acute myocardial infarction (STEMI, NSTEMI) and successfully underwent PCI of the infarct vessel.
  3. Coronary angiography revealed two non-infarct-related arteries with non-blocking lesions (diameter stenosis of 40-70%).
  4. Able to sign informed consent.
  5. Willing to undergo 1-year follow-up.

Exclusion Criteria:

  1. Left main artery disease or severe coronary artery calcification;
  2. Hemodynamic instability or uncontrolled arrhythmia;
  3. History of coronary artery bypass;
  4. 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;
  5. Received any PCSK9 inhibitor treatment within the previous 3 months;
  6. Pregnant or nursing women or women planning pregnancy;
  7. The researcher determined that it was not suitable for inclusion in the group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCSK9 inhibitor group
In this group, patients will receive PCSK9 inhibitor treatment
Drug: PCSK9 inhibitor
The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks 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.
Active Comparator: Statin+ezetimibe group
In this group, patients will receive statin and ezetimibe treatment
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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
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
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
1week；1months；3 months； 6 months; 9 months; 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yun Dai Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCVD2030-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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