None listed
Conditions
Interventions
Drug : Patients are randomly assigned in a 1:1 ratio to either the pitavastatin/ezetimibe combination therapy group (experimental group) or the high-intensity statin monotherapy group (control group).
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 75 years or older ? Patients diagnosed with stable coronary artery disease or acute coronary syndrome and requiring coronary artery intervention due to coronary artery stenosis ? Patients with primary hypercholesterolemia and mixed dyslipidemia ? Patients who understand the risks and benefits of treatment, as well as alternatives, and can voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: ? Patients with hypersensitivity or contraindications to statins or ezetimibe ? Patients with active liver disease or persistently elevated AST or ALT levels exceeding three times the upper limit of normal ? Patients with a history of organ transplantation (kidney, liver, etc.) ? Pregnant or lactating women ? Patients with a life expectancy of less than one year due to non-cardiac disease, or those deemed unable to participate in the study and follow-up (based on the medical judgment of the investigator at each site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major cardiovascular events (cardiovascular death, myocardial infarction, stroke, and unplanned revascularization) | — |
Secondary
| Measure | Time frame |
|---|---|
| Major cardiovascular events (death, cardiovascular death, myocardial infarction, stroke, and unplanned revascularization);Newly diagnosed diabetes;Ratio of patients who achieved LDL < 55 mg/dL;Clinical adverse events (muscle-related adverse events, gastrointestinal symptoms, gallbladder-related adverse events, major bleeding, cancer diagnosis, new-onset neurocognitive disorder, cataract surgery) | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo-young Hahn
Samsung Medical Center
Outcome results
None listed