Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Not Applicable
- Conditions
- Coronary artery diseases
- Registration Number
- JPRN-UMIN000002960
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against statins and ezetimibe 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>10.0 %) 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransferase or alanine aminotransferase exceeds three-fold of the normal limits. 6) Chronic renal failure (serum creatinine>2.0 mg/dl) 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) 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 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
- Secondary Outcome Measures
Name Time Method 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