Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

Study Overview
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Brief Summary
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Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI

Detailed Description
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Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evorukumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.

Official Title
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Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial

Conditions
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Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Intervention / Treatment
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* Drug: Evolocumab 140 MG/ML
* Drug: Rosuvastatin 5mg
* Drug: Ezetimibe 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 19 years old Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form. Patients who underwent percutaneous coronary stenting for acute coronary syndrome Exclusion Criteria: Patients who have previously taken statins, Patients with active liver disease or patients with three times or more increase in AST or ALT If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib, Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study The remaining life expectancy is expected to be less than a year. Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no evolocumab. Rosuvastatin 5 mg and Ezetimibe 10 mg are administered to both the experimental group and the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolocumab treatment group<br>The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period. | Drug: Evolocumab 140 MG/ML<br>* Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe<br>* Other names: REPATHA® (Amgen Inc, Thousand Oaks, California, USA);Drug: Rosuvastatin 5mg<br>* Rosuvastatin 5mg will be assigned to all participants<br>Drug: Ezetimibe 10mg<br>* Ezetimibe 10mg will be assigned to all participants<br>|
| Active Comparator: Group not receiving evolocumab<br>The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg. | Drug: Rosuvastatin 5mg<br>* Rosuvastatin 5mg will be assigned to all participants<br>Drug: Ezetimibe 10mg<br>* Ezetimibe 10mg will be assigned to all participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in LDL level change (mg/dL) | Difference in LDL level change between baseline and 2 weeks later in the test group and control group | Baseline, 2 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL level (%) | Percent change in LDL level at 2 weeks and 4 weeks later compared to baseline in the test group and control group | baseline, 2 weeks later 4 weeks later | 
| Presence or absence of side effects | Presence or absence of side effects (muscle pain, digestive disturbance, test abnormalities) after 2 weeks and 4 weeks of discharge compared to baseline in the test group and control group | baseline, 2 weeks later 4 weeks later | 
| HbA1c(%) level | HbA1c level at 4 weeks later compared to baseline in the test group and control group | 4 weeks | 
| Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level |  | 4 weeks | 
| Creatine kinase(CK) (IU/L) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor