Pemafibrate on vascular functions

JRCT ID: jRCTs061200010

Registered date:17/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertriglyceridemia
• Date of first enrollment: 09/03/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Arm A, pemafibrate (0.2mg to 0.4mg) given on day1 twice a day, until 24 weeks
Arm B, eicosapentaenoic acid (1800mg to 2700mg) given on day1 twice or three times a day, until 24 weeks

Outcome(s)

• Primary Outcome: Change in RHI from baseline determined by Endo-PAT(at 12 weeks)

Secondary Outcome

Change in RHI from baseline determined by Endo-PAT(at 24 weeks)
Association between RHI determined by Endo-PAT and other parameters
Change in boichemical parameters (at 12 and 24 weeks)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Taking statins for three months or more at the time of informed consent
2. Fasting triglyceride over 150 mg/dL or more within 12 weeks before informed consent
3. History of coronary artery diseases including acute coronary syndrome, coronary revascularization, and ischemic heart diseases with significant coronary stenosis or functional ischemia determined by coronary CT, coronary angiography and scintigraphy
4. 20 years old or more at the time of informed consent
5. Understanding study protocol and procedure with written informed consent

Exclude criteria

1. Renal Insufficiency (serum creatinine over 1.5mg/dL or more)
2. Severe liver dysfunction (AST or ALT over 100IU/L or more)
3. Contraindication for pemafibrate and eicosapentaenoic acid
(contraindication of pemafibrate)
1) History of allergy to pemafibrate
2) Severe liver dysfunction, liver cirrhosis with Child-Pugh B or C, biliary obstruction
3) Serum creatinine over 2.5mg/dL or more and creatinine clearance<40mL/min
4) Cholelithiasis
5) Pregnant or potentially pregnant
6) Taking cyclosporine or rifampicin
(contraindication of eicosapentaenoic acid)
1) Bleeding
4. History of acute coronary syndrome within three months before informed consent
5. History of PCI or CABG within three months before informed consent
6. Planning PCI or CABG after informed consent
7. Taking fibrates or omega 3 fatty acids within 12 weeks before informed consent
8. Taking PDE5 inhibitors
9. Fasting triglyceride over 500 mg/dL or more within 12 weeks before informed consent
10. Not meet management criteria of LDL Cholesterol (based on Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017) within 12 weeks before informed consent
11. Secondary dyslipidemia including drug-induced dyslipidemia
12. Primary dyslipidemia including familial hypercholesterolemia
13. Alcoholism
14. Diabetes mellitus with poor control (HbA1c >9.5%) or type 1 diabetes mellitus
15. Vasospastic angina pectoris and microvascular angina pectoris
16. Life expectancy within 6 months

Related Information

• Primary Sponsor: Miyoshi Toru
• Source(s) of Monetary Support: Kowa company Ltd.