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Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm: standard post-treatment for STEMI and Evolocumab | Experimental | The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI |
|
| Control arm: standard post-treatment for STEMI | Active Comparator | Standard post-treatment for STEMI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evolocumab | Drug | Preoperative subcutaneous injection of Evolocumab (420mg),Atorvastatin 40mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average percent change from baseline in LDL-C levels to discharge and day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30 | 30 days | |
| Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30 |
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Inclusion Criteria:
All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.
STEMI patients must meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| rui yan | Contact | 17746570262 | yanrui4112@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing luhe hospital | Recruiting | Beijing | China |
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|
| standard post-treatment for STEMI | Procedure | standard post-treatment for STEMI |
|
| 30 days |
| Number of cardiovascular events to day 30 | 30 days |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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