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Pemafibrate Research to evaluate effect on lower Extremity Vessel lumen after lower Extremity eNdovascular Treatment with drug-coated balloon in patients with hypertriglyceridemia complicated with Lower Extremity Artery Disease; multicenter, prospective, open-label, randomized-controlled trial (PREVENT-LEAD study)

Pemafibrate Research to evaluate effect on lower Extremity Vessel lumen after lower Extremity eNdovascular Treatment with drug-coated balloon in patients with hypertriglyceridemia complicated with Lower Extremity Artery Disease; multicenter, prospective, open-label, randomized-controlled trial (PREVENT-LEAD study)

Matoba Satoaki

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

matoba@koto.kpu-m.ac.jp

Yoshimura Jun

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

+81-75-251-5111

gdmjw395@koto.kpu-m.ac.jp

Recruiting

Feb. 19, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Patients who meet all of the following criteria are included in this study;
1. male and female aged 18 years or older and 85 years or younger at giving their consent
2. patients who have been planed to receive endovascular treatment (EVT) for lower extremity arteriosclerosis obliterans at site/institution that implements this study
3. patients with lower extremity arteriosclerosis obliterans of Fontaine classification II or lower
4. patients with TASC classification A or B by image or ultrasonography
5. patients whose fasting TG was controlled to be 150mg/dL or higher and less than 500mg/dL, or whose casual TG was controlled to be 175mg/dL or higher and less than 500mg/dL throughout 12 weeks before giving their consent
6. patients whose LDL-chol was controlled to be less than 100mg/dL throughout 12 weeks before giving their consent
7. patients with Clinically Frailty Score (CFS) of 7 or lower
8. patients who give their consent in written form from themselves by their free wil

Patients who fall into any of the following criteria are excluded from participating in the study;
1. patients whose life expectancy is considered to be less than 1 year due to other complications
2. patients with history of allegy to pemafibrate or who meet contraindication of pemafibrate
3. patients with eGFR of less than 30ml/min/1.73m2 at giving their consent, or patient with maintenance dialysis
4. patients with extensive gangrene/ulceration that is judged to require early amputation intervention
5. patients with complications of serious infection that are deemed to require early debridement or toe amputation intervention
6. patients requiring treatment (chemotherapy, radiation therapy, surgery, etc.) for active malignant neoplasms
7. patients who are judged to be poor adherence by the responsible investigator or subinvestigators
8. patients who need regal representatives to give their consent
9. patients with other conditions that the responsible investigator or subinvestigators judge inappropriate to participate in the study

Both

lower extremity arteriosclerosis obliterans

<Pemafibrate administration group>
Within 8 weeks after registration/assignment and after tests at observation point 1 (baseline), administration of pemafibrate is initiated orally at a dose of 0.4 mg per day on the day before EVT is performed. The duration of pemafibrate administration in this study is 52 plus/minus 6 weeks.
Concomitant use of fibrates is prohibited, but other dyslipidemic drugs can be added, discontinued, switched, or the dosage changed as appropriate to target LDL-chol of less than 100mg/dL.

<Control group>
After EVT, the same treatment regimen as at the time of consent is continued.
Concomitant use of fibrates is prohibited, but other dyslipidemic drugs can be added, discontinued, switched, or the dosage changed as appropriate to target LDL-chol of less than 100mg/dL.

Change in minimum lumen area (MLA) from EVT implementation to week 52

<Important secondary endpoints>
Change in fasting TG and remnant cholesterol

<Secondary endpoints>
1. change in plaque volume (deltaTAV) in 2.5 cm before and after the MLA site in the treated area by IVUS, change in lumen vascularis, and change in blood vessel diameter at the MLA site
2. change in MLA in non-treated area in the femoral popliteal artery region within the range of IVUS observation
3. presence or absence, or duration of revascularization for the subject limb
4. presence or absence of new ulcer development in the subject or non-subject limbs
5. patency rate (PSVR of 2.4 or higher by lower extremity echography)
6. change in general blood tests (serum LDL-chol, serum HDL-chol, Fibrinogen, D-dimer, CRP, eGFR, VLDL-C, apolipoprotein C-III, apolipoprotein B)
7. change in special blood test (blood sedimentation)

+81-75-251-5337

Dec. 24, 2024

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