UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003938 |
|---|---|
| Receipt number | R000004727 |
| Scientific Title | Ambispective research about the association between adverse event and use of edaravone in patients with acute cerebral infarction. |
| Date of disclosure of the study information | 2010/07/24 |
| Last modified on | 2011/08/23 15:50:01 |
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Basic information
Public title
Ambispective research about the association between adverse event and use of edaravone in patients with acute cerebral infarction.
Acronym
Epidemiological research of Edaravone
Scientific Title
Ambispective research about the association between adverse event and use of edaravone in patients with acute cerebral infarction.
Scientific Title:Acronym
Epidemiological research of Edaravone
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Cardiology | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of adverse ivents (Renal disease, liver injury, thrombocytopenia and intracranial bleeding and Death) and to examine the risk of those events, especially the association of use of edaravone using The Fukuoka Stroke Registry (FSR) data base.(UMIN ID:UMIN000000800)
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal disorder within 21 days.
Key secondary outcomes
Death within 30 days.
And other adverse event, liver injury, thrombocytopenia and intracranial bleeding within 21 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who visited hospital within 24 hours after clinical event and received acute care of cerebral infarction.
Key exclusion criteria
None
Target sample size
6500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Minematsu |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Hayashi |
Organization
Gunma University
Division name
School of health science
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8974
Homepage URL
khayashi@gunma-u.ac.jp
Sponsor or person
Institute
Hisayama Research Institute For Lifestyle Diseases
Graduate School of Medical Sciences, Kyushu University
Gunma University, School of health science
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hisayama Research Institute For Lifestyle Diseases
Graduate School of Medical Sciences, Kyushu University
Gunma University, School of health science
National Cerebral and Cardiovascular Center
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.stroke2011.jp/schedule/pdf/SS-06-7.pdf
Number of participants that the trial has enrolled
Results
27th ICPE: International Conference on Pharmacoepidemiology & Therapeutic Risk Management (Aug 14-17, 2011)
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
| 2009 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
By means of Prospective and Retrospective designs, all acute cerebral infarction patients will be included.
Management information
Registered date
| 2010 | Year | 07 | Month | 22 | Day |
Last modified on
| 2011 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004727
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
