UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011869 |
|---|---|
| Receipt number | R000010068 |
| Scientific Title | Relationship Between Arteriosclerosis Obliterans and Serum Level of Eicosapentaenoic Acid as Prospective Interventional Study |
| Date of disclosure of the study information | 2013/09/26 |
| Last modified on | 2015/01/16 08:44:04 |
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Basic information
Public title
Relationship Between Arteriosclerosis Obliterans and Serum Level of Eicosapentaenoic Acid as Prospective Interventional Study
Acronym
EPA Prospective (EPAP)
Scientific Title
Relationship Between Arteriosclerosis Obliterans and Serum Level of Eicosapentaenoic Acid as Prospective Interventional Study
Scientific Title:Acronym
EPA Prospective (EPAP)
Region
| Japan |
Condition
Condition
Arteriosclerosis Obliterans
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of EPA to ASO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6 minutes walking test
Key secondary outcomes
Fontain's class, ABPI, SPP, ammonia PET, incidence of AMI, stroke and cardiovascular death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilostazol
200 mg/day
6 months
Interventions/Control_2
cilostazol
200 mg /day
eicosapentaenoic acid
1800 mg/day
6 months
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ASO patients with intermittent claudication
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Fukuda |
Organization
National Center for Global Health and Medicine
Division name
Cardiovascular Surgery
Zip code
Address
1-21-1,Toyama,Shinjuku,Tokyo
TEL
03-3202-7181
sfukuda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Secretariat |
Organization
National Center for Global Health and Medicine
Division name
Cardiovascular Surgery
Zip code
Address
1-21-1,Toyama,Shinjuku,Tokyo
TEL
03-3202-7181
Homepage URL
shinzou.gimu@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Department of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
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
国立国際医療研究センター（東京都）
National Center for Global Health and Medicine (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 26 | 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 | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 26 | Day |
Last modified on
| 2015 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010068
