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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025571
Receipt No. R000029427
Scientific Title Tochigi Ryomo EPA/AA Trial in Coronary Artery Disease
Date of disclosure of the study information 2017/01/07
Last modified on 2017/01/07

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Basic information
Public title Tochigi Ryomo EPA/AA Trial in Coronary Artery Disease
Acronym TREAT-CAD
Scientific Title Tochigi Ryomo EPA/AA Trial in Coronary Artery Disease
Scientific Title:Acronym TREAT-CAD
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 coronary artery disease patients with low level of serum EPA/AA ratio
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes the incidence cardiovascular event after an intervention at least 1 year ago
Key secondary outcomes the incidence of all douse death, stroke, hospitalization due to congestive heart failure and/or composite end point of all after an intervention at least 1 year ago

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 High level-control group
serum EPA/AA>or=0.4
Interventions/Control_2 EPA-group
serum EPA/AA<0.4
with 1800mg of purified EPA administration daily
Interventions/Control_3 non-EPA-group
serum EPA/AA<0.4
with 1800mg of purified EPA administration daily
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Coronary artery disease
Key exclusion criteria patient with current bleeding
patients with bleeding tendency and hemorrhagic diathesis
patient with an elective surgical treatment
Patient judged as inappropriate by a physician
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruo Inoue
Organization Dokkyo Medical University
Division name Department of cardiovascular medicine
Zip code
Address Kitakobayashi880 Mibu-machi Simotsuga county, Tochigi
TEL 0282-87-2146
Email inpouet@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shichiro Abe
Organization Dokkyo Medical University
Division name Department of cardiovascular medicine
Zip code
Address Kitakobayashi880 Mibu-machi Simotsuga county, Tochigi
TEL 0282-87-2146
Homepage URL
Email abenana@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of cardiovascular medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nikko Medical Center, Dokkyo Medical University
Sano Kosei General Hospital
Haga Red Cross Hospital
Tochigi Medical Center Shimotsuga
Ustunomiya Memorial Hospital
Koga Hospital
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 07 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 No longer recruiting
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2017 Year 01 Month 07 Day
Last modified on
2017 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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