UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026607 |
|---|---|
| Receipt number | R000030553 |
| Scientific Title | The efficacy of EPA on the clinical outcome in patients with arteriosclerosis obliterans undergoing endvascular treatment: Prospective study |
| Date of disclosure of the study information | 2017/03/18 |
| Last modified on | 2019/09/19 13:35:01 |
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Basic information
Public title
The efficacy of EPA on the clinical outcome in patients with arteriosclerosis obliterans undergoing endvascular treatment: Prospective study
Acronym
arteriosclerosis obliterans and EPA
Scientific Title
The efficacy of EPA on the clinical outcome in patients with arteriosclerosis obliterans undergoing endvascular treatment: Prospective study
Scientific Title:Acronym
arteriosclerosis obliterans and EPA
Region
| Japan |
Condition
Condition
arteriosclerosis obliterans
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effaicy of EPA on clinical outcome in patients with arteriosclerosis obliterans undergoing EVT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Major lower limbs events(revascularization, amputation)
Key secondary outcomes
Fontaine classification,Rutherford classification,6MW,ABI(Ankle Brachial Pressure Index),TBI(toe brachial pressure index),SPP(skin perfusion pressure),Major cardiovascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication: EPA 1800mg/day, Duration: 2 years
Interventions/Control_2
Contrcol
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with arteriosclerosis obliterans
EPA/AA ratio<0.4
Patients who agree to take an informed consent
Key exclusion criteria
Patients with aortic diseae, BK disease, otherresidual vascular disease, formely taking EPA,EVT failure,use of DES,and contraindication of EPA.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ashikaga Takashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular medicine
Zip code
Address
1-5-45 Yushima, Bunkyo ward, Tokyo
TEL
03-5803-5231
sysh.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Yoshikawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular medicine
Zip code
Address
1-5-45 Yushima, Bunkyo ward, Tokyo
TEL
03-5803-5231
Homepage URL
sysh.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
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
東京医科歯科大学（東京都）、横須賀共済病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030553
