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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002171
Receipt No. R000002651
Scientific Title EPA Lipid Intervention and Atherosclerosis Prevention Study-ELIA Study
Date of disclosure of the study information 2009/07/08
Last modified on 2021/06/03

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Basic information
Public title EPA Lipid Intervention and Atherosclerosis Prevention Study-ELIA Study
Acronym ELIA study
Scientific Title EPA Lipid Intervention and Atherosclerosis Prevention Study-ELIA Study
Scientific Title:Acronym ELIA study
Region
Japan

Condition
Condition stable coronary heart disease patients with dyslipidemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examin the effect of EPA on aortic stiffness, lipid profile and oxidative stress
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes relationship among oxidative stress and lipid profile, and aortic stiffness and carotid atherosclerosis
Key secondary outcomes 1)relationship between cardiovascular event and oxidative stress
2)relationship between
inflammatory marker and aortic stiffness
3)relationship between coronary risk factors and oxidative stress

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 statin therapy
Interventions/Control_2 statin+EPA therapy
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria stable coronary heart disease with dyslipidemia (T-CHO>180 mg/dL, LDL-C 100mg/dL)
Key exclusion criteria 1)myocardial infarction within 3 months
2)unstable angina
3)combined severe heart disease
4)post-cardiac intervention within 3 months
5)cerebrovascular disease within 3 months
combined severe hepatic or renal disease
6)malignamcy
7)uncontrolled diabetes
9)secondary dyslipidemia
10)steroid-induced hyperlipidemia
11)familiar hypercholesterolemia
12)bleeding tendency
13)chronic atrial fibrillation
14)pregnancy or expected pregnancy
15)age 70 year-old and or over
16)peripheral artery diase (Fontane2 and more)
17)investigator-decided
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Umemoto
Organization Yamaguchi University Hospital
Division name Pharmaceutical clinical research center
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube Yamaguchi Japan
TEL 0836-22-2663
Email clin_res@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Umemoto
Organization Yamaguchi University Hospital
Division name Pharmaceutical clinical research center
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube Yamaguchi Japan
TEL 0836-22-2663
Homepage URL
Email umemoto@yamaguchi-u.ac.jp

Sponsor
Institute Center for Clinical Research, Yamaguchi University Hospital
Institute
Department

Funding Source
Organization Yamaguchi University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Yamaguchi University Hospital
Address 1-1-1 Minami-Kogushi, Ube, Japan
Tel 0836-22-2663
Email umemoto@yamaguchi-u.ac.jp

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 07 Month 08 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/21701083
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21701083
Number of participants that the trial has enrolled 50
Results EPA may reduce oxidative stress and inhibit the progression of arterial stiffness more efficiently than statin-only therapy in patients with dyslipidemia and CAD.
Results date posted
2021 Year 02 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2011 Year 06 Month 23 Day
Baseline Characteristics There were no significant differences in the baseline clinical characteristics of the patients, except that the statins chosen by the investigators were not the same for all patients; pravastatin was prescribed in the statin-only group, whereas atorvastatin was more preferably prescribed in the combined-therapy group, although all patients in both groups were prescribed a statin as standard therapy.
Participant flow Patients receiving statin therapy for dyslipidemia and with coronary artery disease (CAD) were assigned randomly in an open-label manner to the EPA (1,800 mg/day) -plus-statin group (n= 25; combined-therapy group) or to the statin-only group (n= 25), and followed for 48 weeks.
Adverse events After the randomization, 1 patient in the combined-therapy group and 1 patient in the statin-only group experienced nonfatal myocardial infarction and unstable angina pectoris, respectively.
Outcome measures oxidative stress, the brachial-ankle pulse wave velocity and stiffness parameter B-index of the carotid
Plan to share IPD Depending on the content of the request, it will be provided only to academia researchers under the authority of the principal investigator.
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 02 Month 04 Day
Date of IRB
2003 Year 06 Month 11 Day
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 08 Day
Last modified on
2021 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002651

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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