Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function and markers for inflammation

Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function and markers for inflammation - Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012267

Enrollment

Registered

2013-11-12

Start date

2013-11-12

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

dyslipidemia

Interventions

Administration of bezafibrate Administration of ethyl icosapentate/docosahexaenoate combination

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects with fasting serum triglycerides levels>150mg/dL, or HDL-C levels<40/50 mg/dl (male/female) or remnant like particle cholesterol levels>7.6 2) Subjects with aortic atherosclerotic plaques detected by MRI. 3) Outpatients 4) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against bezafibrate or ethyl icosapentate/docosahexaenoate 2) Poor controlled diabetes mellitus (HbA1c>10%) 3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less) 6) Symptomatic (NYHA III or IV) congestive heart failure 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Severe infection/trauma 10) Subjects who statins treatment is recommended by Guideline of Japan Atherosclerotic Society 2012. 11) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization	—

Secondary

Measure	Time frame
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization. Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization.	—

Measure

Time frame

Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization. Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization.

—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine

ayaori@ndmc.ac.jp04-2995-1617

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026