Patients with coronary artery disease who underwent PCI
Conditions
Interventions
Control therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<
100mg/dL
Aggressive therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<
70mg/dL
Sponsors
Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine
Nozaki Tokushukai Hospital, and Nagoya Tokushukai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients receiving lipid-lowering agents; LDL-C>=100mg/dL, patients not receiving lipid-lowering agents; LDL-C>=110mg/dL 2) Patients 20 years or older at the time of provision of consent 3) Patients giving written consent on their own volition for participation in this clinical trial after being provided with sufficient explanation about the study
Exclusion criteria
Exclusion criteria: 1) Patients scheduled to undergo CABG during the treatment period 2) Patients on steroid treatment 3) Non-availability of evaluable CT images 4) Patients with malignant disease 5) Patients on treatment with fibrates or nicotinic acid 6) Patients with a history of hypersensitivity to any of the components of the product 7) Patients with liver dysfunction (AST or ALT values of >=100IU) or the following diseases considered to be associated with biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus 8) Patients on cyclosporine therapy 9) Pregnant and possibly pregnant women, lactating women 10) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or dialysis patients 11) Patients who are judged by the principal or other investigators to be not eligible for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the coronary plaque distribution and coronary plaque CT values | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in LDL-C, TG, HDL-C 2) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque distribution 3) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque density 4) Correlation between the absolute and percent changes in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque distribution 5) Correlation between the absolute and percent change in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque values 6) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, nonfatal MI, PCI or coronary artery bypass grafting, hospitalization due to angina, fatal or nonfatal stroke or TIA) 7) All-cause mortality | — |
Countries
Japan
Contacts
Public ContactKouichi Tachibana
Osaka University Graduate School of Medicine Department of Advanced Cardiovascular Therapeutics
Outcome results
None listed