A prospective, multicenter, randomized, open-label trial to compare efficacy of pitavastatin plus ezetimibe versus high-dose statin on LDL cholesterol lowering in old age patients (=70) undergoing percutaneous coronary interventio
Not Applicable
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 488
Inclusion Criteria
1)Ages 70 years and older male/female
2)Patients with ASCVD((Atherosclerotic Cardiovascular Disease)) who underwent percutaneous coronary intervention
3)Patient agreed to participate in the protocol
Exclusion Criteria
1)Familial hyperlipidemia
2)LDL-C =100mg/dL after taking high-dose statin or statin/ezetimibe combination therapy
3)Cancer with life expectancy = 1 year
4)History of severe liver disease (Child Pugh B or C)
5)History of hypersensitivity or contraindication to ezetimibe, pitavastatin, or rosuvastatin
6)End-stage renal disease on HD/PD or kidney transplantation
7)Patients who participated in other clinical trial(s) within 3 months after the screening (except non-interventional observational study)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-course changes (% change) in mean serum levels of fasting low density lipoprotein-cholesterol (LDL-C);Time-course changes in SAMS (statin-associated myalgia) questionnaire score
- Secondary Outcome Measures
Name Time Method Change from Baseline in fasting LDL-C target level (55mg/dL) achievement rate ;Change from Baseline in fasting LDL-C target level (70mg/dL) achievement rate ;Change from Baseline in other fasting lipid profile components (high density lipoprotein-cholesterol (HDL-C), triglyceride (TG), total cholesterol (TC), Apolipoprotein B (Apo-B), Apolipoprotein A1 (Apo-A1), Lipoprotein(a), HDL/TG, LDL/HDL ratio, non-HDL/LDL, TC/HDL, Apo-B/Apo-A1 ratio);Change from Baseline in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance), HOMA-ß(Homeostatic Model Assessment for ß cell function );Change from Baseline in serum fasting blood glucose, HbA1c, Fasting serum insulin level ;Change from Baseline in serum AST(ASpartate Transaminase), ALT(ALanine Transaminase) level ;Change from Baseline in serum CPK(creatine phosphokinase), CK-MB(Creatine kinase MB Fraction) level ;Change from Baseline in serum hsCRP(high sensitivity C-Reactive protein) level