UMIN ID: UMIN000001988
Registered date:21/05/2009
Ezetimibe lipid loWering Trial On PreventIon of Atherosclerosis in 75 or older
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hyper-LDL-cholesterolemia |
| Date of first enrollment | 2009/05/01 |
| Target sample size | 6000 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Ezetimibe and diet Diet |
Outcome(s)
| Primary Outcome | 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 Outcome | (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 |
Key inclusion & exclusion criteria
| Age minimum | 75years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Japanese Geriatric Society Public Health Research Foundation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Public Health Research Foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoji Mitadera |
| Address | 1-1-7, nisiwaseda, sinnjyukuku, Tokyo Japan 169-0051 |
| Telephone | 0120-750-741 |
| ewtopia@csp.or.jp | |
| Affiliation | EWTOPIA75 investigators EWTOPIA75 office |
| scientific contact | |
| Name | Yasuyoshi Yasuyoshi Ouchi |
| Address | 2-2-2, toranomon, minatoku, Tokyo Japan |
| Telephone | 03-3588-1111 |
| ewtopia@csp.or.jp | |
| Affiliation | Japanese Geriatric Society Toranomon Hospital - |