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 inflammatio
- Conditions
- dyslipidemia
- Registration Number
- JPRN-UMIN000012267
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 66
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
- Secondary Outcome Measures
Name Time Method 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.