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

Phase 4

Completed

• Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
• Interventions: Drug: Evolocumab 140 MG/ML; Drug: Rosuvastatin 5mg; Drug: Ezetimibe 10mg

• Registration Number: NCT05661552
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-22
• Primary Completion: 2025-02-05
• Study Completion: 2025-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evolocumab treatment group	Ezetimibe 10mg	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.
Evolocumab treatment group	Rosuvastatin 5mg	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.
Evolocumab treatment group	Evolocumab 140 MG/ML	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 not receiving evolocumab	Ezetimibe 10mg	The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.
Group not receiving evolocumab	Rosuvastatin 5mg	The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Primary Outcome Measures

Name	Time	Method
Percent change in LDL level (%)	Baseline, 2 weeks later	Difference in LDL level change between baseline and 2 weeks later in the test group and control group

Secondary Outcome Measures

Name	Time	Method
Percent change in LDL level (%)	baseline, 2 weeks later 4 weeks later	Percent change in LDL level 2 weeks and 4 weeks later compared to baseline in the test group and control group
Differences in LDL level change (mg/dL)	baseline, 2 weeks later 4 weeks later	Differences in LDL level change compared to Baseline between test and control groups
Presence or absence of side effects	baseline, 2 weeks later 4 weeks later	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
Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level	baseline, 2 weeks later 4 weeks later	Liver function test including Aspartate aminotransferase(AST)/alanine
Creatine kinase(CK) (IU/L)	baseline, 2 weeks later 4 weeks later	Creatine kinase(CK) (IU/L)
C-Reactive Protein(CRP) (mg/L)	baseline, 2 weeks later 4 weeks later	C-Reactive Protein(CRP) (mg/L)
Lipoprotein(a) (nmol/L)	baseline, 2 weeks later	Lipoprotein(a) (nmol/L)
HbA1c(%) level	baseline, 4 weeks later	HbA1c level at 4 weeks later compared to baseline in the test group and control group
Cognitive function analysis	2 weeks later	Patients perform self-assessment using a 23-item questionnaire that represents the execution and memory area subscales of all short-lived recognition (ECOG) tools. The cognitive functional analysis scale is evaluated on a 5-point scale, and the lower the score, the better the functional scale.

Trial Locations

Locations (1)

Yongcheol Kim; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of