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 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Not applicable

Started

2024-04-22

Last updated

2025-05-20

Condition(s) studied

Peripheral Artery DiseasePolyvascular Disease

Investigational drug(s) / intervention(s)

Combination therapy of high-intensity dose rosuvastatin and ezetimibeRosuvastatin monotherapy for treat-to-target

Combination therapy of high-intensity dose rosuvastatin and ezetimibe: Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg

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

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

80 Years

Healthy volunteers

Inclusion criteria: 1. Ages 19-80 2. 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 3. 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 Exclusion criteria: 1. Chronic limb threatening ischemia (Rutherford 4\~6) 2. History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months 3. Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal 4. Severe renal dysfunction (eGFR \<30 mL/min/1.73m2) or dependancy on dialysis 5. History of allergic or hypersensitivity reaction to statin or ezetimibe or side effects requiring discontinuation of lipid lowering therapy 6. Solid organ transplant recipients 7. Pregnant women, potentially pregnant or lactating women 8. Life expectancy of less than 3 years 9. When follow-up for more than 1 year is not possible 10. Inability to understand or read the consent form

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06231966 on ClinicalTrials.gov ↗ ← All trials in South Korea