UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010452 |
|---|---|
| Receipt number | R000012101 |
| Scientific Title | Effects of EPA on Cardiovascular Events Markers in Patients with Coronary Arery Disease |
| Date of disclosure of the study information | 2013/04/11 |
| Last modified on | 2015/10/26 10:56:16 |
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Basic information
Public title
Effects of EPA on Cardiovascular Events Markers in Patients with Coronary Arery Disease
Acronym
EPA and Cardiovascular Markers
Scientific Title
Effects of EPA on Cardiovascular Events Markers in Patients with Coronary Arery Disease
Scientific Title:Acronym
EPA and Cardiovascular Markers
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was investigate the effects of EPA on cardiovascular biomarker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in inflammatory biomarker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of EPA
Interventions/Control_2
Control
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
| 35 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with CAD.
Key exclusion criteria
The exclusion criteria included inability to obtain consent, current treatment with n-3PUFAs.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Department of Cardiology, Surugadai Nihon University Hospital
Division name
Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL
03-3293-1711
tanishigem@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Surugadai Nihon University Hospital
Division name
Cardiology
Zip code
Address
1-8-13 kandasurugadai, Chiyodaku, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
tanishigem@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, Surugadai Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
This work was supported by KAKENHI Grant Number 23590757 of the Japan Society for the Promotion of Science (JSPS).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012101
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
