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

Not Applicable

Not yet recruiting

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: PCSK9 inhibitor; Drug: Statin+ezetimibe; Behavioral: Blood lipid levels meet the recommended guidelines; Behavioral: Blood lipid levels don't meet the recommended guidelines

• Registration Number: NCT06854523
• Lead Sponsor: Yun Dai Chen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-04-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCSK9 inhibitor group	PCSK9 inhibitor	In this group, patients will receive PCSK9 inhibitor treatment
PCSK9 inhibitor group	Blood lipid levels meet the recommended guidelines	In this group, patients will receive PCSK9 inhibitor treatment
Statin+ezetimibe group	Statin+ezetimibe	In this group, patients will receive statin and ezetimibe treatment
Statin+ezetimibe group	Blood lipid levels don't meet the recommended guidelines	In this group, patients will receive statin and ezetimibe treatment

Primary Outcome Measures

Name	Time	Method
Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.	12 months	IPA is a quantitative analysis tool based on OCT technology to evaluate plaque stability.
Changes in pericoronary artery fat attenuation index (FAI) measured by CCTA for non-culprit lesions at baseline and 12 months of follow-up	12 months	FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.

Secondary Outcome Measures

Name	Time	Method
Progress of target lesion plaques	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.
The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups	12 months	MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization
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

Trial Locations

Locations (2)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital [; 🇨🇳 Beijing, China