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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCSK9 inhibitor group | Experimental | In this group, patients will receive PCSK9 inhibitor treatment |
|
| Statin+ezetimibe group | Active Comparator | In this group, patients will receive statin and ezetimibe treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progress of target lesion plaques | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Li | Contact | 8613810545564 | lidandan5564@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| Statin+ezetimibe | Drug | 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 | Behavioral | 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 | Behavioral | The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids |
|
| 12 months |
| The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups | 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 | 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 |
| Chinese PLA General Hospital [ | Beijing | China |
|