Acute Coronary Syndrome, Clinical Trial
Conditions
Keywords
evolocumab, Spectroscopy, Near-Infrared
Brief summary
This study aimed to investigate the impact of intensive cholesterol-lowering therapy (including evolocumab), drug treatment for high-risk plaques (Vulnerable plaques) with a high probability of developing acute coronary syndrome. The purpose of this study is to determine the effect of the change in the Lipid core burden index and compare the rate of cardiac events over 12 months following cholesterol therapy.
Interventions
DRUGEvolocumab
The maximum dose of combined cholesterol therapy (Statin + Ezetimibe) is prescribed for 2 months, and a cholesterol test is performed in an outpatient clinic to ensure that LDL-Cholesterol \<70mg/dL is met. Patients who do not meet the criteria are randomized to maintain current treatment or receive additional Evolocumab according to randomization.
DEVICENIRS IVUS
near-infrared spectroscopy
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 19 years old 2. Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information 3. Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome 4. Patients who did not meet the LDL-Cholesterol level (\<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months
Exclusion criteria
1. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) 2. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 3. Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration 4. Those whose surviving life is expected to be less than 1 year 5. Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment 6. Subjects participating in a randomized study on cholesterol therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of 1-year lipid core burden index | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of All cause mortality | 1 year | — |
| Percentage of cardiac death | 1 year | — |
| Percentage of myocardial infarction | 1 year | — |
| patient-oriented composite end point | 1 year | composite of all cause mortality, any myocardial infarction, and any revascularization |
| Rate of usage of cholesterol lowering agents (2 month) | 1 year | — |
| Rate of usage of cholesterol lowering agents (12 month) | 1 year | — |
| Percentage of revascularization | 1 year | — |
Countries
South Korea
Outcome results
None listed