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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: Administration of bezafibrate Administration of ethyl icosapentate/docosahexaenoate combination CONDITION: dyslipidemia PRIMARY OUTCOME: Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization SECONDARY OUTCOME: 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. 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
Epistemonikos ID: 4fe9b790a61b4a09b6082b20257dec373b633895
First added on: Aug 22, 2024