Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI (C-STAR)

Yonsei University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Ezetimibe 10mg; Drug: Evolocumab 140 MG/ML; Drug: Rosuvastatin 5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05661552

9-2022-0119

Details and patient eligibility

About

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

Full description

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.

Enrollment: 108 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Evolocumab treatment group

Experimental group

Description:

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.

Treatment:

Drug: Rosuvastatin 5mg

Drug: Evolocumab 140 MG/ML

Drug: Ezetimibe 10mg

Group not receiving evolocumab

Active Comparator group

Description:

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

Treatment:

Drug: Rosuvastatin 5mg

Drug: Ezetimibe 10mg