Comparing a combination of rosuvastatin and ezetimibe to rosuvastatin alone for patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.