About this trial
Patients with atherosclerotic peripheral artery disease often have combined coronary artery disease or cerebral artery disease and show high rates of cardiovascular mortality and morbidities. Therefore, secondary prevention for these patients is of great clinical importance. Currently, Korean, US, and European guidelines recommend different LDL cholesterol target goals in patients with peripheral artery disease. In recent clinical trials, combination therapy of statin plus ezetimibe demonstrated improved cardiovascular outcomes compared with statin monotherapy. Thus, the purpose of the CARE-PVD study is to investigate whether the combination therapy of high intensity rosuvastatin 20 mg plus ezetimibe 10 mg can improve cardiovascular outcomes in patient with peripheral artery disease or polyvascular artery disease in comparison with rosuvastatin treat-to-target (LDL cholesterol \<70 mg/dL) monotherapy.
Eligibility criteria
Qualifiers
Ages 19-80
Patient with arteriosclerotic lower extremity artery disease or multivessel disease 1) Arteriosclerotic lower extremity artery disease: If any of the following applies
Ankle-brachial index <0.85 with symptoms of intermittent claudication
Lower extremity artery stenosis of more than 50% on imaging tests
Disqualifiers
Chronic limb threatening ischemia (Rutherford 4~6)
History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months
Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal
Severe renal dysfunction (eGFR <30 mL/min/1.73m2) or dependancy on dialysis
Trial design
Treatments tested in this trial
- Combination therapy of high-intensity dose rosuvastatin and ezetimibe
- Rosuvastatin monotherapy for treat-to-target