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Completed

NCT Number: NCT05661552

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

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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Key information

Conditions

Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yongcheol Kim

Yongin, Gyeonggi-do, 16995, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolocumab 140 MG/ML

Drug

Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe

Other names: REPATHA® (Amgen Inc, Thousand Oaks, California, USA)

Rosuvastatin 5mg

Drug

Rosuvastatin 5mg will be assigned to all participants

Ezetimibe 10mg

Drug

Ezetimibe 10mg will be assigned to all participants

Primary outcomes

  1. Percent change in LDL level (%)

    Time frame: Baseline, 2 weeks later

    Difference in LDL level change between baseline and 2 weeks later in the test group and control group

Secondary outcomes

  1. Percent change in LDL level (%)

    Time frame: 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

  2. Differences in LDL level change (mg/dL)

    Time frame: baseline, 2 weeks later 4 weeks later

    Differences in LDL level change compared to Baseline between test and control groups

  3. Presence or absence of side effects

    Time frame: 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

  4. Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level

    Time frame: baseline, 2 weeks later 4 weeks later

    Liver function test including Aspartate aminotransferase(AST)/alanine

  5. Creatine kinase(CK) (IU/L)

    Time frame: baseline, 2 weeks later 4 weeks later

    Creatine kinase(CK) (IU/L)

  6. C-Reactive Protein(CRP) (mg/L)

    Time frame: baseline, 2 weeks later 4 weeks later

    C-Reactive Protein(CRP) (mg/L)

  7. Lipoprotein(a) (nmol/L)

    Time frame: baseline, 2 weeks later

    Lipoprotein(a) (nmol/L)

  8. HbA1c(%) level

    Time frame: baseline, 4 weeks later

    HbA1c level at 4 weeks later compared to baseline in the test group and control group

  9. Cognitive function analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Registry information

Official study title

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

Acronym: C-STAR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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