Hypertriglyceridemia
Conditions
Interventions
Arm A, pemafibrate (0.2mg to 0.4mg) given on day1 twice a day or day1 once a day until 24 weeks
Arm B, eicosapentaenoic acid (1800mg to 2700mg) given on day1 twice or three times a day, until 24 weeks
Sponsors
Miyoshi Toru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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) Cholelithiasis 4) Pregnant or potentially pregnant 5) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in RHI from baseline determined by Endo-PAT(at 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactToru Miyoshi
Okayama University Hospital
Outcome results
None listed