Ezetimibe lipid loWering Trial On PreventIon of Atherosclerosis in 75 or older

UMIN ID: UMIN000001988

Registered date:21/05/2009

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

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

• Source(s) of Monetary Support: Public Health Research Foundation