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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003938
Receipt No. 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

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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
Email

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
Email khayashi@gunma-u.ac.jp

Sponsor
Institute Hisayama Research Institute For Lifestyle Diseases
Graduate School of Medical Sciences, Kyushu University
Gunma University, School of health science
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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