NIPH Clinical Trials Search

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) studiedHyper-LDL-cholesterolemia
Date of first enrollment2009/05/01
Target sample size6000
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ezetimibe and diet Diet


Primary OutcomeComposite 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 minimum75years-old
Age maximumNot applicable
GenderMale 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


public contact
Name Yoji Mitadera
Address 1-1-7, nisiwaseda, sinnjyukuku, Tokyo Japan 169-0051
Telephone 0120-750-741
Affiliation EWTOPIA75 investigators EWTOPIA75 office
scientific contact
Name Yasuyoshi Yasuyoshi Ouchi
Address 2-2-2, toranomon, minatoku, Tokyo Japan
Telephone 03-3588-1111
Affiliation Japanese Geriatric Society Toranomon Hospital -