Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease

Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease - PEMA-FLOW study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061403

Enrollment

Registered

2026-05-05

Start date

2026-05-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower extremity artery disease (LEAD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage change from baseline in capillary blood flow velocity around the dorsalis pedis artery at 12 weeks.	—

Secondary

Measure	Time frame
Change from baseline in capillary blood flow velocity around the dorsalis pedis artery at 12 weeks Change and percentage change in capillary blood flow velocity around the dorsalis pedis artery at 24 weeks from baseline and from 12 weeks Change and percentage change from baseline for the following items at 12 weeks: Capillary blood flow velocity in the fingertips and nail folds ABI, TBI Various blood test items Change and percentage change from baseline and from 12 weeks for the following items at 24 weeks: Capillary blood flow velocity in the fingertips and nail folds ABI, TBI Various blood test items	—

Measure

Time frame

Change from baseline in capillary blood flow velocity around the dorsalis pedis artery at 12 weeks Change and percentage change in capillary blood flow velocity around the dorsalis pedis artery at 24 weeks from baseline and from 12 weeks Change and percentage change from baseline for the following items at 12 weeks: Capillary blood flow velocity in the fingertips and nail folds ABI, TBI Various blood test items Change and percentage change from baseline and from 12 weeks for the following items at 24 weeks: Capillary blood flow velocity in the fingertips and nail folds ABI, TBI Various blood test items

—

Countries

Japan

Contacts

Public ContactYoichiro Otaki

Yamagata University School of Medicine Department of Cardiology, Pulmonology, and Nephrology

y-otaki@med.id.yamagata-u.ac.jp023-628-5302

Outcome results