NCT06231966

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,462 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Artery Disease
• Polyvascular Disease

Interventions

Type	Name	Description
DRUG	Combination therapy of high-intensity dose rosuvastatin and ezetimibe	Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg
DRUG	Rosuvastatin monotherapy for treat-to-target	Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \<70 mg/dL)

Timeline

• Start date: 2024-04-22
• Primary completion: 2026-05-06
• Completion: 2029-05-06
• First posted: 2024-01-30
• Last updated: 2025-05-20

Locations

1 site across 1 country: South Korea