UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061403 |
|---|---|
| Receipt number | R000069782 |
| Scientific Title | Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease |
| Date of disclosure of the study information | 2026/05/05 |
| Last modified on | 2026/04/28 15:20:40 |
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Basic information
Public title
Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease
Acronym
Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease
Scientific Title
Effect of Pemafibrate on capillary red blood cell Flow, microvascular perfusion, and blood whole blood viscosity in patients with lower extremity arterial disease
Scientific Title:Acronym
PEMA-FLOW study
Region
| Japan |
Condition
Condition
Lower extremity artery disease (LEAD)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change from baseline in capillary blood flow velocity around the dorsalis pedis artery at 12 weeks.
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
990-9585
Address
Iidanishi 2-2-2, Yamagata
TEL
023-628-5302
m-watanabe@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Otaki |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
990-9585
Address
Iidanishi2-2-2, Yamagata
TEL
023-628-5302
Homepage URL
y-otaki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata Uniersity School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KOWA COMPANY, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Ethics Committee of the Yamagata University School of Medicine
Address
Iidanishi2-2-2
Tel
023-628-5047
yu-ikekenkyu@jm.kj.yamagata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山形大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069782
