Actively Recruiting
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)
Led by Yonsei University · Updated on 2025-05-20
2462
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 19 to 80 years
- Patients diagnosed with arteriosclerotic lower extremity artery disease or multivessel disease
- For lower extremity artery disease: ankle-brachial index below 0.85 with symptoms, or more than 50% artery narrowing on imaging, or history of related intervention or surgery
- For multivessel disease: presence of at least two among coronary artery disease, carotid artery stenosis over 50% or ischemic stroke/transient cerebral ischemia, or large thoracic/abdominal aortic aneurysm
- Patients currently taking medication for dyslipidemia or with LDL cholesterol above 70 mg/dL and not on lipid-lowering medication
You will not qualify if you...
- Chronic limb threatening ischemia (Rutherford stages 4 to 6)
- History of acute coronary syndrome, stroke/transient ischemic attack, or lower limb amputation within 6 months
- Acute liver disease or persistent unexplained elevation of liver enzymes more than twice the normal limit
- Severe kidney dysfunction (eGFR less than 30 mL/min/1.73m2) or dialysis dependency
- Allergic or hypersensitivity reaction to statin or ezetimibe or previous side effects requiring stopping lipid-lowering therapy
- Solid organ transplant recipients
- Pregnant, potentially pregnant, or breastfeeding women
- Life expectancy less than 3 years
- Inability to commit to follow-up for more than 1 year
- Inability to understand or read the consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young-Guk Ko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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