UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025571 |
|---|---|
| Receipt number | 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 | 2020/01/10 09:36:32 |
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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 | Teruo |
| Middle name | |
| Last name | Inoue |
Organization
Dokkyo Medical University
Division name
Department of cardiovascular medicine
Zip code
321-0293
Address
Kitakobayashi880 Mibu-machi Simotsuga county, Tochigi
TEL
0282-87-2146
inpouet@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Shichiro |
| Middle name | |
| Last name | Abe |
Organization
Dokkyo Medical University
Division name
Department of cardiovascular medicine
Zip code
321-0293
Address
Kitakobayashi880 Mibu-machi Simotsuga county, Tochigi
TEL
0282-87-2146
Homepage URL
abenana@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Department of cardiovascular medicine
Institute
Department
Personal name
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
Dokkyo Medial University
Address
KItakobayashi880, Mibu-machi Shimotsuga
Tel
0282-86-1111
y-tasaki@dokkyomed.ac.jp
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
816
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
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
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029427
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/01/10 | TREAT-CAD実施要綱.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/01/10 | TREAT-CAD実施要綱.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/01/10 | TREAT-CAD実施要綱.docx |
