Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Conditions
Keywords
acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor
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.
Interventions
Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe
DRUGRosuvastatin 5mg
Rosuvastatin 5mg will be assigned to all participants
DRUGEzetimibe 10mg
Ezetimibe 10mg will be assigned to all participants
Sponsors
Daewoong Pharmaceutical Co. LTD.
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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. |
| C-Reactive Protein(CRP) (mg/L) | baseline, 2 weeks later 4 weeks later | C-Reactive Protein(CRP) (mg/L) |
Countries
South Korea
Outcome results
None listed