KCT0009107
Recruiting
未知
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)
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 2462
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 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
Outcomes
Primary Outcomes
Not specified
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