Tokyo, May 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061403) titled 'Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease' on May 5.

Study Type: Observational

Primary Sponsor: Institute - Yamagata Uniersity School of Medicine

Condition: Condition - Lower extremity artery disease (LEAD) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of the present is to examine the effect of pemafibrate on the blood viscosity in patients with LEAD. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 or older at the time of obtaining consent Patients with lower extremity obstructive arteriosclerosis*1) Patients who have had a plasma fibrinogen level of 325 mg/dL or higher at least once within 24 weeks prior to obtaining consent Patients scheduled to receive pemafibrate for the treatment of hyperlipidemia*2) Patients who have provided written consent from the subject themselves Key exclusion criteria - Patients with a history of lower limb amputation due to peripheral artery disease Patients who received oral anticoagulants for peripheral artery disease within 12 weeks prior to obtaining consent Patients with atrial fibrillation, collagen disease, or severe anemia Patients receiving treatment for malignant tumors Patients receiving hemodialysis Patients whose dyslipidemia medication was changed within 12 weeks prior to obtaining consent Patients for whom pemafibrate administration is contraindicated Patients with a history of hypersensitivity to the components of this drug Patients with severe liver impairment, Child-Pugh class B or C cirrhosis or patients with biliary obstruction Patients with gallstones Pregnant women or women who may be pregnant Patients receiving cyclosporine or rifampicin Patients receiving triglyceride-lowering therapy Patients deemed inappropriate by the principal investigator or co-investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 22 Day Date of IRB - 2026 Year 12 Month 22 Day Anticipated trial start date - 2026 Year 05 Month 05 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069782

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