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)

Not Applicable

Recruiting

• Conditions: Polyvascular Disease; Peripheral Artery Disease
• Interventions: Drug: Combination therapy of high-intensity dose rosuvastatin and ezetimibe; Drug: Rosuvastatin monotherapy for treat-to-target

• Registration Number: NCT06231966
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2023-12-08
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-30
• Study Start: 2024-04-22
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-05-06
• Study Completion: 2029-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2462

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin/ezetimibe combination therapy	Combination therapy of high-intensity dose rosuvastatin and ezetimibe	Combination therapy of high-intensity dose rosuvastatin and ezetimibe
Rosuvastatin monotherapy	Rosuvastatin monotherapy for treat-to-target	Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \< 70 mg/dL)

Primary Outcome Measures

Name	Time	Method
Composite of Major cardiovascular event or major adverse limb event	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 Outcome Measures

Name	Time	Method
discontinuation of lipid lowering therapy	at 1, 2, and 3 years	Intolerance of lipid lowering therapy
Major cardiovascular event : non-fatal myocardial infarction	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 cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)	at 1, 2, and 3 years	Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
adverse clinical events related to lipid lowering therapy	at 1, 2, and 3 years	adverse clinical events related to lipid lowering therapy
attainment of LDL cholesterol	attainment of LDL cholesterol goal	at 1, 2, and 3 years

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of