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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001988
Receipt No. R000002426
Scientific Title Ezetimibe lipid loWering Trial On PreventIon of Atherosclerosis in 75 or older
Date of disclosure of the study information 2009/05/21
Last modified on 2018/10/12

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Basic information
Public title Ezetimibe lipid loWering Trial On PreventIon of Atherosclerosis in 75 or older
Acronym EWTOPIA75
Scientific Title Ezetimibe lipid loWering Trial On PreventIon of Atherosclerosis in 75 or older
Scientific Title:Acronym EWTOPIA75
Region
Japan

Condition
Condition Hyper-LDL-cholesterolemia
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Endocrinology and Metabolism Hematology and clinical oncology Nephrology
Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the preventive effects of a cholesterol absorption inhibitor, ezetimibe on cardiovascular events in old patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes (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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Ezetimibe and diet
Interventions/Control_2 Diet
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) High-risk outpatients with hyper-LDL-cholesterolemia (serum LDL-cholesterol levels &#8805; 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
Key exclusion criteria (1)Serum TG level &#8805; 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&#8805;100 IU/L 2. ALT&#8805;100 IU/L 3. liver chirosis
(7) Serum creatinine level &#8805;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
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Ouchi, MD, PhD
Organization Japanese Geriatric Society
Toranomon Hospital
Division name -
Zip code
Address 2-2-2, toranomon, minatoku, Tokyo
TEL 03-3588-1111
Email ewtopia@csp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Eto, MD, PhD
Organization EWTOPIA75 investigators
Division name EWTOPIA75 office
Zip code
Address 1-1-7, nisiwaseda, sinnjyukuku, Tokyo
TEL 0120-750-741
Homepage URL http://csp.or.jp/ld/ewtopia/
Email ewtopia@csp.or.jp

Sponsor
Institute Japanese Geriatric Society
Public Health Research Foundation
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 21 Day

Related information
URL releasing protocol http://csp.or.jp/ld/ewtopia/index.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 21 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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