Clinical trial NCT05661552: Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Keywords: acute coronary syndrome
low-density-lipoprotein
PCSK9 inhibitor
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2022-12-22
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in LDL level (%)
timeFrame: Baseline, 2 weeks later
Secondary outcomes:
measure: Percent change in LDL level (%)
timeFrame: baseline, 2 weeks later 4 weeks later
measure: Differences in LDL level change (mg/dL)
timeFrame: baseline, 2 weeks later 4 weeks later
measure: Presence or absence of side effects
timeFrame: baseline, 2 weeks later 4 weeks later
measure: Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level
timeFrame: baseline, 2 weeks later 4 weeks later
measure: Creatine kinase(CK) (IU/L)
timeFrame: baseline, 2 weeks later 4 weeks later
measure: C-Reactive Protein(CRP) (mg/L)
timeFrame: baseline, 2 weeks later 4 weeks later
measure: Lipoprotein(a) (nmol/L)
timeFrame: baseline, 2 weeks later
measure: HbA1c(%) level
timeFrame: baseline, 4 weeks later
measure: Cognitive function analysis
timeFrame: 2 weeks later
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongcheol Kim
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Yongcheol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: