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)
Overview
- Phase
- Not Applicable
- Intervention
- Combination therapy of high-intensity dose rosuvastatin and ezetimibe
- Conditions
- Peripheral Artery Disease
- Sponsor
- Yonsei University
- Enrollment
- 2462
- Locations
- 1
- Primary Endpoint
- Composite of Major cardiovascular event or major adverse limb event
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
* A multicenter prospective randomized controlled clinical trial * A total of 2462 subjects with cperipheral artery disease or polyvascular disease will be included according to inclusion and exclusion criteria. * Patients will be randomized in a 1:1 manner into the rosuvastatin/ezetimibe combination therapy group or rosuvastatin monotherapy group. • The randomization will be startified by previous use of statin and presence of diabetes mellitus. • In the rosuvastatin/ezetimibe combination therapy group, rosuvastatin 20 mg plus ezetimibe 10 mg will be administered. • In the rosuvastatin monotherapy group, rosuvastatin will be administered and the dose of rosuvastatin will be adjusted to attain the target LDL cholesterol level \< 70 mg/dL. * Patients will be followed clinically for 3years. * The primary endpoint is defined as the composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rosuvastatin/ezetimibe combination therapy
Combination therapy of high-intensity dose rosuvastatin and ezetimibe
Intervention: Combination therapy of high-intensity dose rosuvastatin and ezetimibe
Rosuvastatin monotherapy
Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \< 70 mg/dL)
Intervention: Rosuvastatin monotherapy for treat-to-target
Outcomes
Primary Outcomes
Composite of Major cardiovascular event or major adverse limb event
Time Frame: at 3 years
Composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up MACE includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure. MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries.
Secondary Outcomes
- discontinuation of lipid lowering therapy(at 1, 2, and 3 years)
- Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)(at 1, 2, and 3 years)
- Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)(at 1, 2, and 3 years)
- adverse clinical events related to lipid lowering therapy(at 1, 2, and 3 years)
- attainment of LDL cholesterol(at 1, 2, and 3 years)
- Major cardiovascular event : non-fatal myocardial infarction(at 1, 2, and 3 years)