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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe
Rosuvastatin 5mg will be assigned to all participants
Ezetimibe 10mg will be assigned to all participants
Yongcheol Kim
Yongin, Gyeonggi-do, South Korea
Percent change in LDL level (%)
Difference in LDL level change between baseline and 2 weeks later in the test group and control group
Time frame: Baseline, 2 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
Time frame: 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
Time frame: baseline, 2 weeks later 4 weeks later
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
Time frame: 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
Time frame: baseline, 2 weeks later 4 weeks later
Creatine kinase(CK) (IU/L)
Creatine kinase(CK) (IU/L)
Time frame: baseline, 2 weeks later 4 weeks later
C-Reactive Protein(CRP) (mg/L)
C-Reactive Protein(CRP) (mg/L)
Time frame: baseline, 2 weeks later 4 weeks later
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Lipoprotein(a) (nmol/L)
Lipoprotein(a) (nmol/L)
Time frame: baseline, 2 weeks later
HbA1c(%) level
HbA1c level at 4 weeks later compared to baseline in the test group and control group
Time frame: 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.
Time frame: 2 weeks later