Peripheral Artery DiseaseNCT06231966
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)
A study testing Combination therapy of high-intensity dose rosuvastatin and ezetimibe and Rosuvastatin monotherapy for treat-to-target in people with Peripheral Artery Disease and Polyvascular Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, Polyvascular Disease
- What is being tested?
- Combination therapy of high-intensity dose rosuvastatin and ezetimibe and Rosuvastatin monotherapy for treat-to-target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,462 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2024to 6 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Young-Guk Ko, MD, PhD, 02)-2228-8460, ygko@yuhs.ac
About this study
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.
Read the detailed description
- A multicenter prospective randomized controlled clinical trial
- A total of 2462 subjects with cperipheral artery disease or polyvascular disease will be included according to inclusion and exclusion criteria.
- 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.
- Patients will be followed clinically for 3years.
- The primary endpoint is defined as the composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up.
- Conditions
- Peripheral Artery Disease, Polyvascular Disease
- Being tested
- Combination therapy of high-intensity dose rosuvastatin and ezetimibe, Rosuvastatin monotherapy for treat-to-target
- Keywords
- Peripheral artery disease, polyvascular disease, lipid lowering therapy, LDL cholesterol, Clinical outcomes
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy of high-intensity dose rosuvastatin and ezetimibeDrug
Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg
Rosuvastatin monotherapy for treat-to-targetDrug
Rosuvastatin monotherapy for treat-to-target (LDL cholesterol <70 mg/dL)
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin/ezetimibe combination therapy | Experimental | Combination therapy of high-intensity dose rosuvastatin and ezetimibe Receives: Drug: Combination therapy of high-intensity dose rosuvastatin and ezetimibe |
| Rosuvastatin monotherapy | Active comparator | Rosuvastatin monotherapy for treat-to-target (LDL cholesterol < 70 mg/dL) Receives: Drug: Rosuvastatin monotherapy for treat-to-target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Major cardiovascular event or major adverse limb event
Composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up MACE includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure. MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries.
Measured: at 3 years
Secondary outcomes (6)
Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Measured: at 1, 2, and 3 years
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
Measured: at 1, 2, and 3 years
discontinuation of lipid lowering therapy
Intolerance of lipid lowering therapy
Measured: at 1, 2, and 3 years
adverse clinical events related to lipid lowering therapy
adverse clinical events related to lipid lowering therapy
Measured: at 1, 2, and 3 years
attainment of LDL cholesterol
attainment of LDL cholesterol goal
Measured: at 1, 2, and 3 years
Major cardiovascular event : non-fatal myocardial infarction
Measured: at 1, 2, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start22 Apr 2024
- Primary completion6 May 2026 (estimated)
- Study completion6 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231966
- Sponsor's protocol ID
- 4-2023-1212
- Status last verified
- May 2025
- First submitted
- 8 Dec 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 4-2023-1212
- Conditions
- Peripheral Artery Disease, Polyvascular Disease
- Keywords
- Peripheral artery disease, polyvascular disease, lipid lowering therapy, LDL cholesterol, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,462 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 6 May 2026 (estimated)
- Study completion
- 6 May 2029 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- A multicenter prospective randomized controlled clinical trial
- A total of 2462 subjects with cperipheral artery disease or polyvascular disease will be included according to inclusion and exclusion criteria.
- 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.
- Patients will be followed clinically for 3years.
- The primary endpoint is defined as the composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin/ezetimibe combination therapy | Experimental | Drug: Combination therapy of high-intensity dose rosuvastatin and ezetimibeCombination therapy of high-intensity dose rosuvastatin and ezetimibe |
| Rosuvastatin monotherapy | Active comparator | Drug: Rosuvastatin monotherapy for treat-to-targetRosuvastatin monotherapy for treat-to-target (LDL cholesterol < 70 mg/dL) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination therapy of high-intensity dose rosuvastatin and ezetimibeCombination therapy of rosuvastatin 20 mg and ezetimibe 10 mg | Drug | Rosuvastatin/ezetimibe combination therapy |
| Rosuvastatin monotherapy for treat-to-targetRosuvastatin monotherapy for treat-to-target (LDL cholesterol <70 mg/dL) | Drug | Rosuvastatin monotherapy |
Primary outcome
Composite of Major cardiovascular event or major adverse limb event
Time frame: at 3 years
Composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up MACE includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure. MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries.
6 secondary outcomes
Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Time frame: at 1, 2, and 3 years
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
Time frame: at 1, 2, and 3 years
discontinuation of lipid lowering therapy
Time frame: at 1, 2, and 3 years
adverse clinical events related to lipid lowering therapy
Time frame: at 1, 2, and 3 years
attainment of LDL cholesterol
Time frame: at 1, 2, and 3 years
Major cardiovascular event : non-fatal myocardial infarction
Time frame: at 1, 2, and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination therapy of high-intensity dose rosuvastatin and ezetimibe and Rosuvastatin monotherapy for treat-to-target in people with Peripheral Artery Disease and Polyvascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Guk Ko, MD, PhD (02)-2228-8460, ygko@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Major cardiovascular event or major adverse limb event (time frame: at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.