UMIN-CTR Clinical Trial

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
Email	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
Email	sysh.cvm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030553