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Compares treatment options for Peripheral Artery Disease
Official title 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)
ClinicalTrials.gov ID: NCT06231966
What this study is testing
What is Combination therapy of high-intensity dose rosuvastatin and ezetimibe?
Combination therapy of high-intensity dose rosuvastatin and ezetimibe is an investigational medicine, being studied as a potential treatment for peripheral artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients with atherosclerotic peripheral artery disease often have combined coronary artery disease or cerebral artery disease and show high rates of cardiovascular mortality and morbidities. Therefore, secondary prevention for these patients is of great clinical importance.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- Ages 19-80
- Patient with arteriosclerotic lower extremity artery disease or multivessel disease 1) Arteriosclerotic lower extremity artery disease: If any of the...
- Ankle-brachial index \<0.85 with symptoms of intermittent claudication
- Lower extremity artery stenosis of more than 50% on imaging tests
- History of receiving treatment or surgical treatment for lower extremity artery disease) 2) Arteriosclerotic multivessel disease: When at least two...
You likely can't join if
- Chronic limb threatening ischemia (Rutherford 4\~6)
- History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months
- Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal
- Severe renal dysfunction (eGFR \<30 mL/min/1.73m2) or dependancy on dialysis
- History of allergic or hypersensitivity reaction to statin or ezetimibe or side effects requiring discontinuation of lipid lowering therapy
- Solid organ transplant recipients
See the full eligibility criteria
- Ages 19-80
- 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 treatment 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...
- 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
- 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
- Chronic limb threatening ischemia (Rutherford 4\~6)
- History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months
- Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal
- Severe renal dysfunction (eGFR \<30 mL/min/1.73m2) or dependancy on dialysis
- History of allergic or hypersensitivity reaction to statin or ezetimibe or side effects requiring discontinuation of lipid lowering therapy
- Solid organ transplant recipients
- Pregnant women, potentially pregnant or lactating women
- Life expectancy of less than 3 years
- When follow-up for more than 1 year is not possible
- Inability to understand or read the consent form
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.