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)

NCT06231966 | Recruiting DMC

• 1 other identifier: 4-2023-1212
• Study Type: interventional
• Target: 2,462
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Polyvascular Disease

Keywords

Peripheral artery disease; polyvascular disease; lipid lowering therapy; LDL cholesterol; Clinical outcomes

Outcome Measures

Primary Outcomes (1)

• Composite of Major cardiovascular event or major adverse limb event

  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.

  at 3 years

Secondary Outcomes (6)

• 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

• discontinuation of lipid lowering therapy

  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

Study Arms (2)

Rosuvastatin/ezetimibe combination therapy

EXPERIMENTAL

Combination therapy of high-intensity dose rosuvastatin and ezetimibe

Drug: Combination therapy of high-intensity dose rosuvastatin and ezetimibe

Rosuvastatin monotherapy

ACTIVE COMPARATOR

Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \< 70 mg/dL)

Drug: Rosuvastatin monotherapy for treat-to-target

Interventions

Combination therapy of high-intensity dose rosuvastatin and ezetimibe DRUG

Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg

Rosuvastatin/ezetimibe combination therapy

Rosuvastatin monotherapy for treat-to-target DRUG

Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \<70 mg/dL)

Rosuvastatin monotherapy

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• History of receiving interventional or surgical treatment for lower extremity artery disease) 2) Arteriosclerotic multivessel disease: When at least two of the following diseases exist even if there is no lower extremity artery disease
• Coronary artery disease
• History of carotid artery stenosis (more than 50%) or ischemic stroke/transient cerebral ischemia event
• degenerative thoracic (maximum diameter \>4 cm) or abdominal (maximum diameter \>3cm) aortic aneurysm
• Patients on medication for dyslipidemia or patients with LDL cholesterol level higher than the target level for peripheral arterial disease (≥70 mg/dL) and not on lipid lowering medication

You may not qualify if:

• 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
• History of allergic or hypersensitivity reaction to statin or ezetimibe or side effects requiring discontinuation of lipid lowering therapy
• Solid organ transplant recipients
• Pregnant women, potentially pregnant or lactating women
• Life expectancy of less than 3 years
• When follow-up for more than 1 year is not possible
• Inability to understand or read the consent form

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Young-Guk Ko, MD, PhD

CONTACT

02)-2228-8460; ygko@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 30, 2024
• Study Start: April 22, 2024
• Primary Completion: May 6, 2026
• Study Completion (Estimated): May 6, 2029
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)