UMIN-CTR Clinical Trial

Basic information
Public title	Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia
Acronym	KEEP(Kyushu Elderly Ezetimibe Phytosterol study)
Scientific Title	Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia
Scientific Title:Acronym	KEEP(Kyushu Elderly Ezetimibe Phytosterol study)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of ezetimibe on cholesterol absorption-synthesis and inflammation markers and cardiovascular events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	0 to 24weeks (1)changes in cholesterol absorption and synthesis (2)changes in inflammation markers (3)changes in lipoproteins(RLPcholesterol, small dense LDL etc), oxydised phospholipid, oxdised cholesterol) (4)NT-proBNP
Key secondary outcomes	relation to composite cardiovascular events(same as EWTOPIA75)

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
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 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 level400 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. AST100 IU/L 2. ALT100 IU/L 3. liver chirosis (7) Serum creatinine level3.0 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	1300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Sasaki,MD,PhD
Organization	International University of Health and Welfare
Division name	Department of medical treatment for health
Zip code
Address	2-4-16 Momochihama Sawaraku,Fukuoka,Japan
TEL	092-407-0434
Email	fukuoka-shiken@iuhw.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Jun Sasaki,MD,PhD
Organization	International University of Health and Welfare
Division name	Department of medical treatment for health
Zip code
Address	2-4-16 Momochihama Sawaraku,Fukuoka,Japan
TEL	092-407-0434
Homepage URL
Email	fukuoka-shiken@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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Tel
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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	国際医療福祉大学

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 02 Day

Related information
URL releasing protocol
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	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2015 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020583

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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