Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.
- Conditions
- coronary artery disease
- Registration Number
- JPRN-UMIN000002698
- Lead Sponsor
- ational Hospital Organization, Kure Medical Center and Chugoku Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1) Patients with more than 500mg/dL of triglyceride. 2) Patients with hepatic dysfunction [ALT>3 x upper limit of normal range.] 3) Patients with renal dysfunction [Serum creatinine >2 x upper limit of normal range] 4) Patients with a history of myocardial infarction, unstable angina, CABG operation or stroke within recent 3 months. 5) Patients with uncontrolled diabetes mellitus (HbA1c>9%). 6) Patients with a history of drug-allergy (shock, anaphylaxis, vascular edema). 7) Patients taking immune-suppressor. 8) Patients with familial hypercholesterolemia. 9) Patients with secondary hyperlipidemia. 10) Alcohol abusers. 11) Patients with drug-induced hyperlipidemia (steroid, or other medicine) 12) Pregnant or possibly pregnant women. Those who want or are wanted by the partner to be pregnant. 13) Patients hypersensitive with this medicine and /or contaminants of this medicine. 14) Patients who are judged to be inappropriate as a subject by a doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of LDL-C
- Secondary Outcome Measures
Name Time Method 1) Changes of RLP-C, hs-CRP, lipid peroxidation, Non HDL-C, Non HDL-C/HDL-C, LDL-C/HDL-C, TC, TG, HDL-C. 2) Change of insulin resistance.