UMIN-CTR Clinical Trial

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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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 Mitadera
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	Completed
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 10 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 10 Month 03 Day

Other
Other related information

Management information
Registered date	2009 Year 05 Month 21 Day
Last modified on	2020 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002426

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