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)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 2,462 人开始时间: 待定最近更新: 2024年7月23日

适应症

试验速览

暂无简介。

•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

•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

发起方