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)

Peripheral Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231966
• Other study ID #: 4-2023-1212
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: May 6, 2029

Study information

• Verified date: January 2024
• Source: Yonsei University
• Contact: Young-Guk Ko, MD, PhD
• Phone: 02)-2228-8460
• Email: ygko[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

- A multicenter prospective randomized controlled clinical trial - A total of 2452 subjects with peripheral 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 stratified 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2452
• Est. completion date: May 6, 2029
• Est. primary completion date: May 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Polyvascular Disease

Intervention

Drug:
• Combination therapy of high-intensity dose rosuvastatin and ezetimibe
Combination therapy of rosuvastatin 20 mg and ezetimibe 10 mg
• Rosuvastatin monotherapy for treat-to-target
Rosuvastatin monotherapy for treat-to-target (LDL cholesterol <70 mg/dL)

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 3 years
Secondary	discontinuation of lipid lowering therapy	Each components of the primary endpoint, Intolerance of lipid lowering therapy, adverse clinical events related to lipid lowering therapy, attainment of LDL cholesterol goal at 1, 2, and 3-year follow-up	at 1, 2, and 3 years
Secondary	adverse clinical events related to lipid lowering therapy	Each components of the primary endpoint, Intolerance of lipid lowering therapy, adverse clinical events related to lipid lowering therapy, attainment of LDL cholesterol goal at 1, 2, and 3-year follow-up	at 1, 2, and 3 years
Secondary	attainment of LDL cholesterol	Each components of the primary endpoint, Intolerance of lipid lowering therapy, adverse clinical events related to lipid lowering therapy, attainment of LDL cholesterol goal at 1, 2, and 3-year follow-up	at 1, 2, and 3 years