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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 16995
      • Yongcheol Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Evolocumab 140 MG/ML; Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe; Other Names: REPATHA® (Amgen Inc, Thousand Oaks, California, USA); Drug: Rosuvastatin 5mg; Rosuvastatin 5mg will be assigned to all participants; Drug: Ezetimibe 10mg; Ezetimibe 10mg will be assigned to all participants
Active Comparator: Group not receiving evolocumab; The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.	Drug: Rosuvastatin 5mg; Rosuvastatin 5mg will be assigned to all participants; Drug: Ezetimibe 10mg; Ezetimibe 10mg will be assigned to all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in LDL level (%)	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
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
Percent change in LDL level (%)	Percent change in LDL level 2 weeks and 4 weeks later compared to baseline in the test group and control group	baseline, 2 weeks later 4 weeks later
Differences in LDL level change (mg/dL)	Differences in LDL level change compared to Baseline between test and control groups	baseline, 2 weeks later 4 weeks later
Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level	Liver function test including Aspartate aminotransferase(AST)/alanine	baseline, 2 weeks later 4 weeks later
Creatine kinase(CK) (IU/L)	Creatine kinase(CK) (IU/L)	baseline, 2 weeks later 4 weeks later
C-Reactive Protein(CRP) (mg/L)	C-Reactive Protein(CRP) (mg/L)	baseline, 2 weeks later 4 weeks later
Lipoprotein(a) (nmol/L)	Lipoprotein(a) (nmol/L)	baseline, 2 weeks later
HbA1c(%) level	HbA1c level at 4 weeks later compared to baseline in the test group and control group	baseline, 4 weeks later
Cognitive function analysis	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.	2 weeks later

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Yongcheol Kim, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: acute coronary syndrome; PCSK9 inhibitor; low-density-lipoprotein
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Myocardial Ischemia; Acute Coronary Syndrome; Hyperlipidemias; Hyperlipoproteinemias; PCSK9 Inhibitors; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Serine Proteinase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Ezetimibe; Evolocumab
• Other Study ID Numbers: 9-2022-0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No