Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial functio
Not Applicable
- Conditions
- Dyslipidemia
- Registration Number
- JPRN-UMIN000011745
- 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
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against rosuvastatin or ezetimibe 2) Poor-controlled diabetes (HbA1c>10.0 %) 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) End stage renal disease 6) Symptomatic (NYHA III or IV) congestive heart failure 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 (1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIMT/maxIMT) and plaque score) 12/24 months after randomization (2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI) 12/24 months after randomization (3) Flow-mediated vasodilation in forearm 6 months after randomization
- Secondary Outcome Measures
Name Time Method (1) Ankle/brachial index and cardio ankle vascular index (2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (3) Serum lipids (4) Markers indicating obesity (e.g. adiponectin) (5) Markers indicating inflammation (e.g. high sensitive CRP) (6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (7) Markers indicating chronic renal diseases (urine albumin/L-FABP) (8) Blood/urine urate levels (9) Body weight/waist circumference (10) Blood pressures