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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005303
Receipt No. R000006297
Scientific Title Efficacy of pretreatment with edaravone on cerebral blood flow in carotid artery stenting.
Date of disclosure of the study information 2011/04/01
Last modified on 2018/12/03

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Basic information
Public title Efficacy of pretreatment with edaravone on cerebral blood flow in carotid artery stenting.
Acronym Efficacy of pretreatment with edaravone on cerebral blood flow in carotid artery stenting.
Scientific Title Efficacy of pretreatment with edaravone on cerebral blood flow in carotid artery stenting.
Scientific Title:Acronym Efficacy of pretreatment with edaravone on cerebral blood flow in carotid artery stenting.
Region
Japan

Condition
Condition Carotid stenosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of pretreatment with edaravone on cerebral blood flow using single photon emission computed tomography in carotid artery stenting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of cerebral blood flow using single photon emission computed tomography.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients will be randomly selected to receive edaravone. Intravenous administration of edaravone (60mg) before carotid artery stenting.
Interventions/Control_2 Patients will also be randomly selected to receive treatment with conventional therapy.
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
20 years-old <=
Age-upper limit
86 years-old >
Gender Male and Female
Key inclusion criteria Patients with carotid artery stenosis of 70% and more in symptomatic stenosis, and 80% and more in asymptomatic stenosis.
Key exclusion criteria 1)Renal dysfunction(Cre>=1.5mg/dL)
2)Hepatic function disorder
(AST>=100IU/L or ALT>=100IU/l,total bilirubin>=2.5mg/dL)
3)Plt<100,000/mm3
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takenobu Kunieda
Organization Kansai Medical University
Division name Department of Neurology
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takenobu Kunieda
Organization Kansai Medical University
Division name Department of Neurology
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Neurology, Kansai Medical University
Institute
Department

Funding Source
Organization Department of Neurology, Kansai Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2011 Year 03 Month 24 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006297

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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