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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-02-05

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

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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 Evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.

Conditions

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Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolocumab treatment group

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.

Group Type EXPERIMENTAL

Evolocumab 140 MG/ML

Intervention Type DRUG

Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe

Rosuvastatin 5mg

Intervention Type DRUG

Rosuvastatin 5mg will be assigned to all participants

Ezetimibe 10mg

Intervention Type DRUG

Ezetimibe 10mg will be assigned to all participants

Group not receiving evolocumab

The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Group Type ACTIVE_COMPARATOR

Rosuvastatin 5mg

Intervention Type DRUG

Rosuvastatin 5mg will be assigned to all participants

Ezetimibe 10mg

Intervention Type DRUG

Ezetimibe 10mg will be assigned to all participants

Interventions

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Evolocumab 140 MG/ML

Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

Rosuvastatin 5mg will be assigned to all participants

Intervention Type DRUG

Ezetimibe 10mg

Ezetimibe 10mg will be assigned to all participants

Intervention Type DRUG

Other Intervention Names

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REPATHA® (Amgen Inc, Thousand Oaks, California, USA)

Eligibility Criteria

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Inclusion Criteria

1. Over 19 years old
2. 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.
3. Patients who underwent percutaneous coronary stenting for acute coronary syndrome

Exclusion Criteria

1. Patients who have previously taken statins,
2. Patients with active liver disease or patients with three times or more increase in AST or ALT
3. If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
4. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
5. The remaining life expectancy is expected to be less than a year.
6. Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment
7. Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No