Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction (ACCESS-AMI)
NCT ID: NCT06854523
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2025-04-15
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCSK9 inhibitor group
In this group, patients will receive PCSK9 inhibitor treatment
PCSK9 inhibitor
The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months
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.
Statin+ezetimibe group
In this group, patients will receive statin and ezetimibe treatment
Statin+ezetimibe
The patient used statins and ezetimibe within 24 hours before or after PCI, and then once a day for 12 months
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
Interventions
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PCSK9 inhibitor
The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months
Statin+ezetimibe
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
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
The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Yun Dai Chen
OTHER
Responsible Party
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Yun Dai Chen
professor
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital [
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ASCVD2030-6
Identifier Type: -
Identifier Source: org_study_id
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