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)
Launched by YONSEI UNIVERSITY · Jan 21, 2024

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Nctid: NCT06231966

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MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries."}], "secondaryOutcomes"=>[{"measure"=>"Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)", "timeFrame"=>"at 1, 2, and 3 years", "description"=>"Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)"}, {"measure"=>"Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)", "timeFrame"=>"at 1, 2, and 3 years", "description"=>"Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)"}, {"measure"=>"discontinuation of lipid lowering therapy", "timeFrame"=>"at 1, 2, and 3 years", "description"=>"Intolerance of lipid lowering therapy"}, {"measure"=>"adverse clinical events related to lipid lowering therapy", "timeFrame"=>"at 1, 2, and 3 years", "description"=>"adverse clinical events related to lipid lowering therapy"}, {"measure"=>"attainment of LDL cholesterol", "timeFrame"=>"attainment of LDL cholesterol goal", "description"=>"at 1, 2, and 3 years"}, {"measure"=>"Major cardiovascular event : non-fatal myocardial infarction", "timeFrame"=>"at 1, 2, and 3 years"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Peripheral artery disease", "polyvascular disease", "lipid lowering therapy", "LDL cholesterol", "Clinical outcomes"], "conditions"=>["Peripheral Artery Disease", "Polyvascular Disease"]}, "descriptionModule"=>{"briefSummary"=>"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. Currently, Korean, US, and European guidelines recommend different LDL cholesterol target goals in patients with peripheral artery disease. In recent clinical trials, combination therapy of statin plus ezetimibe demonstrated improved cardiovascular outcomes compared with statin monotherapy. Thus, the purpose of the CARE-PVD study is to investigate whether the combination therapy of high intensity rosuvastatin 20 mg plus ezetimibe 10 mg can improve cardiovascular outcomes in patient with peripheral artery disease or polyvascular artery disease in comparison with rosuvastatin treat-to-target (LDL cholesterol \\<70 mg/dL) monotherapy.", "detailedDescription"=>"* A multicenter prospective randomized controlled clinical trial\n* A total of 2462 subjects with cperipheral artery disease or polyvascular disease will be included according to inclusion and exclusion criteria.\n* Patients will be randomized in a 1:1 manner into the rosuvastatin/ezetimibe combination therapy group or rosuvastatin monotherapy group. • The randomization will be startified by previous use of statin and presence of diabetes mellitus. • In the rosuvastatin/ezetimibe combination therapy group, rosuvastatin 20 mg plus ezetimibe 10 mg will be administered. • In the rosuvastatin monotherapy group, rosuvastatin will be administered and the dose of rosuvastatin will be adjusted to attain the target LDL cholesterol level \\< 70 mg/dL.\n* Patients will be followed clinically for 3years.\n* The primary endpoint is defined as the composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"19 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria:\n\n1. Ages 19-80\n2. Patient with arteriosclerotic lower extremity artery disease or multivessel disease 1) Arteriosclerotic lower extremity artery disease: If any of the following applies\n\n * Ankle-brachial index \\<0.85 with symptoms of intermittent claudication\n * Lower extremity artery stenosis of more than 50% on imaging tests\n * 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\n * Coronary artery disease\n * History of carotid artery stenosis (more than 50%) or ischemic stroke/transient cerebral ischemia event 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\n\nExclusion criteria:\n\n1. Chronic limb threatening ischemia (Rutherford 4\\~6)\n2. History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months\n3. Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal\n4. Severe renal dysfunction (eGFR \\<30 mL/min/1.73m2) or dependancy on dialysis\n5. History of allergic or hypersensitivity reaction to statin or ezetimibe or side effects requiring discontinuation of lipid lowering therapy\n6. Solid organ transplant recipients\n7. Pregnant women, potentially pregnant or lactating women\n8. Life expectancy of less than 3 years\n9. When follow-up for more than 1 year is not possible\n10. Inability to understand or read the consent form"}, "identificationModule"=>{"nctId"=>"NCT06231966", "briefTitle"=>"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)", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "officialTitle"=>"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)", "orgStudyIdInfo"=>{"id"=>"4-2023-1212"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Rosuvastatin/ezetimibe combination therapy", "description"=>"Combination therapy of high-intensity dose rosuvastatin and ezetimibe", "interventionNames"=>["Drug: Combination therapy of high-intensity dose rosuvastatin and ezetimibe"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Rosuvastatin monotherapy", "description"=>"Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \\< 70 mg/dL)", "interventionNames"=>["Drug: Rosuvastatin monotherapy for treat-to-target"]}], "interventions"=>[{"name"=>"Combination therapy of high-intensity dose rosuvastatin and ezetimibe", "type"=>"DRUG", "description"=>"Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg", "armGroupLabels"=>["Rosuvastatin/ezetimibe combination therapy"]}, {"name"=>"Rosuvastatin monotherapy for treat-to-target", "type"=>"DRUG", "description"=>"Rosuvastatin monotherapy for treat-to-target (LDL cholesterol \\<70 mg/dL)", "armGroupLabels"=>["Rosuvastatin monotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Young-Guk Ko, MD, PhD", "role"=>"CONTACT", "email"=>"ygko@yuhs.ac", "phone"=>"02)-2228-8460"}], "facility"=>"Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Young-Guk Ko, MD, PhD", "role"=>"CONTACT", "email"=>"ygko@yuhs.ac", "phone"=>"02)-2228-8460"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Peripheral Artery Disease Polyvascular Disease Lipid Lowering Therapy Ldl Cholesterol Clinical Outcomes

ClinConnect Summary

The CARE-PVD Trial is a research study designed to find out if a combination of two medications—high-intensity rosuvastatin and ezetimibe—can better help patients with peripheral artery disease or polyvascular disease compared to taking rosuvastatin alone. Peripheral artery disease affects blood flow in the legs, and patients with this condition often have other heart and blood vessel issues. This trial aims to see if lowering cholesterol levels more effectively can improve heart health and reduce risks of serious health problems.

To participate in this trial, individuals must be between 19 and 80 years old and have specific types of artery disease, such as problems in the arteries of the legs or issues with heart and brain arteries. The study is currently looking for participants, and those who join can expect to be assigned randomly to either the combination treatment or the single medication treatment. It’s important to know that certain individuals, like those with severe kidney problems or recent serious heart issues, will not be eligible to participate. If you think you might be eligible or want to learn more, consider discussing this with your healthcare provider.

Gender

ALL

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 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

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

People applied

0 patients applied

Timeline

First submit

December 08, 2023

Trial launched

April 22, 2024

Trial updated

July 16, 2024

Estimated completion

Not reported

Discussion 0

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) Launched by YONSEI UNIVERSITY · Jan 21, 2024

Frequently Asked Questions About Clinical Trials

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)
Launched by YONSEI UNIVERSITY · Jan 21, 2024