Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06231966
Study type Interventional
Source Yonsei University
Contact Young-Guk Ko, MD, PhD
Phone 02)-2228-8460
Email ygko@yuhs.ac
Status Not yet recruiting
Phase N/A
Start date February 2024
Completion date May 6, 2029

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05712395 - The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease N/A
Active, not recruiting NCT04534257 - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Completed NCT02554266 - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed NCT03921905 - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting NCT06369350 - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion Early Phase 1
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed NCT02522884 - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries N/A
Completed NCT02563535 - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia Phase 4
Completed NCT02542267 - In-Stent Restenosis Post-Approval Study N/A
Completed NCT02145065 - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r) N/A
Completed NCT02262949 - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System N/A
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Completed NCT01743872 - Optical Imaging Measurement of Intravascular Solution Efficacy Trial N/A
Recruiting NCT01424020 - Walking Estimated Limitation Calculated by History - Study 2 Phase 4
Active, not recruiting NCT01597453 - NOR-SYS: The Norwegian Stroke in the Young Study N/A