Patients with stable coronary artery disease
Conditions
Interventions
Sponsors
Public Health Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who met following all criteria were entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) (1) Coronary artery disease patients Meeting one of following events 1) History of Acute Coronary Syndrome (AMI or Unstable angina) 2) History of revascularization (PCI or CABG) 3) Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification (2) Hypercholesterolemia patients Meeting one of following criteria 1) LDL-C is 140 mg/dL or over 2) LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians 3) Patents receiving cholesterol lowering drugs (3) Age (20<= <80 year-old) (4) Patients given written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria(1) (Pre-Run-in period) 1. Patients planed revascularization 2. Malignant tumor in active phase 3. Patients who meet contraindication of LIVALO tablet below 1) Patients who have hypersensitivity to LIVALO tablet 2) Patients who have severe liver dysfunction or biliary atresia. 3)Patients who are being treated with cyclosporine 4) Pregnant women, women suspected of being pregnant, or lactating women 4. Patients who have heart failure NYHA III or greater 5. Patients undergoing dialysis 6. Patients with familial hypercholesterolemia 7. Patients registered in the other clinical trials 8. Patients with prohibited drugs 9. Patients who are ineligible in the opinion of the investigator Exclusion Criteria(2) (Post-Run-in period) 1. LDL-C is 120mg/dL or over after Run-in period 2. Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months 3. Patients who have been undergone PCI or CABG within 3 months 4. Compliance is less than 50% in Run-in period 5. Patients who met primary endpoint or adverse events in Run-in period and judged as ineligible in the opinion of the investigator 6. Patients who are ineligible in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of one of following events 1. Cardiovascular death 2. Non-fatal Myocardial Infarction 3. Non-fatal Cerebral Infarction 4.Unstable angina requiring urgent hospitalizations | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Composite cardiovascular events Occurrence of one of following events Cardiovascular death, Non-fatal MI, Non-fatal CI, Unstable angina requiring hospitalizations, Ischemia-driven coronary revascularization except target lesion revascularization (TLR) 2. Composite coronary heart disease events Occurrence of one of following events Coronary heart disease (CHD) death, Non-fatal MI, Unstable angina requiring urgent hospitalizations, Ischemia-driven coronary revascularization except TLR. 3.Composite cerebrovascular events Occurrence of one of following events Fatal and Non-fatal stroke, Transient ischemic attack (TIA) requiring hospitalizations. 4.Death events Occurrence of each following events All-cause mortality Cardiovascular death Cardiac death CHD death 5.Heart disease events Occurrence of each following events Fatal and Non-fatal MI Non-procedure related MI Procedure related MI Unstable angina requiring urgent hospitalizations Resuscitated cardiac arrest Hospitalization for heart failure PCI or CABG (1)All events of PCI or CABG (a)TLR (b)non-TLR (2)Ischemia-driven PCI or CABG (a)TLR (b)non-TLR 6. Cerebrovascular events Occurrence of each following events Fatal and Non-fatal stroke Fatal and Non-fatal CI (1) Non-procedure related CI (2) Procedure related CI Fatal and Non-fatal cerebral hemorrhage Hospitalization for TIA 7. The other events Occurrence of each following events Operation for or rupture of aortic aneurysm Revascularization for peripheral arterial disease (PAD) Carotid artery stenting (CAS) or carotid endarterectomy (CEA) Aortic dissection Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) New occurrence of malignant tumor Operation for aortic stenosis | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactTeruhiko Miyazaki
Public Health Research Foundation Comprehensive Support Project for Clinical Research
Outcome results
None listed