Comparing a combination of rosuvastatin and ezetimibe to rosuvastatin alone for patients with peripheral artery disease
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)
This study is testing if taking both rosuvastatin and ezetimibe together can help people with peripheral artery disease have fewer heart and leg problems compared to just taking rosuvastatin alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2462 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06231966 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a high-intensity combination therapy of rosuvastatin and ezetimibe compared to rosuvastatin monotherapy in patients with peripheral artery disease or polyvascular disease. A total of 2462 participants will be randomly assigned to receive either the combination therapy or rosuvastatin alone, with the primary endpoint being the occurrence of major cardiovascular or limb events over a three-year follow-up period. The study aims to determine if the combination therapy can lead to better cardiovascular outcomes than the standard treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19-80 with atherosclerotic lower extremity artery disease or multivessel disease.
Not a fit: Patients without peripheral artery disease or polyvascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with peripheral artery disease, potentially reducing cardiovascular events.
How similar studies have performed: Previous studies have shown that combination therapy with statins and ezetimibe can improve cardiovascular outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Young-Guk Ko, MD, PhD
- Email: ygko@yuhs.ac
- Phone: 02)-2228-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.