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)
| NCT ID | NCT06231966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,462 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2026-05-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,462 participants in total. It began in 2024-04-22 with a primary completion date of 2026-05-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06231966 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06231966 currently recruiting?
Yes, NCT06231966 is actively recruiting participants. Contact the research team at ygko@yuhs.ac for enrollment information.
Where is the NCT06231966 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06231966 clinical trial?
NCT06231966 is sponsored by Yonsei University. The trial plans to enroll 2,462 participants.