UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002171 |
|---|---|
| Receipt number | 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 11:16:06 |
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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
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
umemoto@yamaguchi-u.ac.jp
Sponsor or person
Institute
Center for Clinical Research, Yamaguchi University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002651
