Clinical trial NCT06854523: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Pericoronary artery fat attenuation index
Index of Plaque Attenuation
PCSK9 Inhibitor
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.
timeFrame: 12 months
measure: Changes in pericoronary artery fat attenuation index (FAI) measured by CCTA for non-culprit lesions at baseline and 12 months of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Progress of target lesion plaques
timeFrame: 12 months
measure: The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups
timeFrame: 12 months
measure: The proportion of LDLC at each visit node that meets the recommended guidelines and the changes compared to baseline
timeFrame: 1week；1months；3 months； 6 months; 9 months; 12 months
measure: Changes in inflammatory factors (interleukin 6, C reaction protein) at each visit node compared to baseline
timeFrame: 1week；1months；3 months； 6 months; 9 months; 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital [
Study officials:
References: