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

NCT06854523 | Not Yet Recruiting DMC

• 1 other identifier: ASCVD2030-6
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; Pericoronary artery fat attenuation index; Index of Plaque Attenuation; PCSK9 Inhibitor

Outcome Measures

Primary Outcomes (2)

• Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.

  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

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

  12 months

Secondary Outcomes (4)

• Progress of target lesion plaques

  12 months

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

  12 months

• The proportion of LDLC at each visit node that meets the recommended guidelines and the changes compared to baseline

  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

  1week；1months；3 months； 6 months; 9 months; 12 months

Study Arms (2)

PCSK9 inhibitor group

EXPERIMENTAL

In this group, patients will receive PCSK9 inhibitor treatment

Drug: PCSK9 inhibitor; Behavioral: Blood lipid levels meet the recommended guidelines

Statin+ezetimibe group

ACTIVE COMPARATOR

In this group, patients will receive statin and ezetimibe treatment

Drug: Statin+ezetimibe; Behavioral: Blood lipid levels don't meet the recommended guidelines

Interventions

PCSK9 inhibitor DRUG

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

PCSK9 inhibitor group

Statin+ezetimibe DRUG

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

Statin+ezetimibe group

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.

PCSK9 inhibitor group

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

Statin+ezetimibe group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yun Dai Chen: lead

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Chinese PLA General Hospital [

Beijing, China

Location

Central Study Contacts

Dandan Li

CONTACT

8613810545564; lidandan5564@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: March 3, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-09

Locations

CN (2)