Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT06231966
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06231966
Study Brief:
Protocol Section:
NCT06231966