UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008055 |
|---|---|
| Receipt number | R000009487 |
| Scientific Title | Sub-study on genetic markers responsible to effects of HMG-CoA reductase inhibitor preventing recurrence of stroke |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2023/06/08 10:07:53 |
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Basic information
Public title
Sub-study on genetic markers responsible to effects of HMG-CoA reductase inhibitor preventing recurrence of stroke
Acronym
J-STARS Genomics
Scientific Title
Sub-study on genetic markers responsible to effects of HMG-CoA reductase inhibitor preventing recurrence of stroke
Scientific Title:Acronym
J-STARS Genomics
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to clarify the genetic markers responsible to the recurrence of stroke and cognitive impairment in order to establish diagnosis and treatment for patients with stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Genetic markers responsible to the high risk of stroke recurrence , efficacy of HMG-CoA inhibitor, and appearance of cognitive impairment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)The enrolled subjects in JSTARS study
(2)The subjects from whom the informed consent was obtained
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masayasu |
| Middle name | |
| Last name | Matsumoto |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5201
naika3@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nezu |
Organization
Hiroshima University Graduate School of Biomedical Sciences
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
734-8551
Address
1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5201
Homepage URL
http://jstars.umin.ne.jp
naika3@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Translational Research Center for Medical Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
signpost corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Medical Policy Office
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5555
iryo-seisaku@office.hiroshima-u.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
| 2012 | Year | 06 | Month | 01 | 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 | 03 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Recurrence of Stroke
Dementia
Management information
Registered date
| 2012 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009487
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
