Hyper-LDL-cholesterolemia
Conditions
Interventions
Sponsors
Japanese Geriatric Society Public Health Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) High-risk outpatients with hyper-LDL-cholesterolemia (serum LDL-cholesterol levels>140mg/dL) aged 75 years and older (at the time of written informed consent) of the both sexes (LDL-cholesterol levels are calculated with Friedewald Formula). (2) At least one of the following factors 1. DM 2. Hypertension 3. Low-HDL-cholesterolemia 4. Hypertriglyceridemia 5. Current smoking 6. History of cerebral infarction 7. PAD
Exclusion criteria
Exclusion criteria: (1) Serum TG level> 400 mg/dL (2) History of myocardial infarction (3) History of PCI or CABG (4) Angina pectoris requiring treatment (5) Recent history of stroke(within 6 months) (6) 1. AST>100 IU/L 2. ALT>100 IU/L 3. liver chirosis (7) Serum creatinine level >3.0 mg/dL (8) Cancer (9) Dementia (10) Familial hyperchoresterolemia (11) Atrial fibrillation (12) Allergy to ezetimibe (13) Patients participating in other clinical trials (14) Patients inappropriate for the trial judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite cardiovascular events (1)Cardiac sudden death (2)Fatal myocardial infarction (3)Non-fatal myocardial infarction (4)PCI or CABG (5)Fatal stroke (6)Non-fatal stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Composite coronary events (cardiac sudden death, fatal myocardial infarction or non-fatal myocardial infarction) Cardiac sudden death Fatal or non-fatal myocardial infarction PCI or CABG Fatal or non-fatal stroke Fatal stroke Non-fatal stroke Fatal or non-fatal cerebral infarction Fatal cerebral infarction Non-fatal cerebral infarction TIA Fatal or non-fatal cerebral hemorrhage Fatal cerebral hemorrhage Non-fatal cerebral hemorrhage CAS or CEA Revascularization for PAD (EVT or bypass operation) Aortic dissection Rupture of aortic aneurysm Operation for aortic aneurysm (2) All-cause death Cardiovascular death (cardiac sudden death, fatal myocardial infarction or fatal stroke) Non-cardiovascular death Death for cancer (3) All-cause hospitalization Hospitalization for cardiovascular causes Hospitalization for non-cardiovascular causes (4) Cancer Femoral neck fracture Dementia MMSE GDS15 ADL (TMIG Index for Competence) Admission to nursing homes (5) Adverse events (6) Cost | — |
Countries
Japan
Contacts
Public ContactYoji Mitadera
EWTOPIA75 investigators EWTOPIA75 office
Outcome results
None listed