Randomized Comparison of Efficacy and Safety of High-intensity Rosuvastatin/Ezetimibe Combination Versus Treat-to-target Rosuvastatin Monotherapy for Patients With Peripheral Artery or Polyvascular Disease (CARE-PVD Trial)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorYonsei University

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

Treatment groups

2,462 Participants
are divided into 2 treatment groups

Sponsors and collaborators