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

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0009107

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2462

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 the following two 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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of major cardiovascular event or major adverse limb event

Secondary Outcome Measures

Name	Time	Method
Each components of the primary endpoint;Discontiation of the study lipid lowering therapy due to intolerance;Adverse clinical events related to study lipid lowering therapy;Attainment of LDL cholesterol goal