UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005303 |
|---|---|
| Receipt number | 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 | 2021/03/31 15:58:53 |
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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 | Takenobu |
| Middle name | |
| Last name | Kunieda |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
0728040101
kuniedta@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takenobu |
| Middle name | |
| Last name | Kunieda |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
TEL
0728040101
Homepage URL
kuniedta@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Neurology, Kansai Medical University
Institute
Department
Personal name
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
Kansai Medical University
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191 Japan
Tel
072-804-0101
kenkyu@hirakata.kmu.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
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
https://doi.org/10.1016/j.inat.2021.101092
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.inat.2021.101092
Number of participants that the trial has enrolled
52
Results
Of the 51 patients, 3 (6%) had CHP, including one with transient postprocedural hypotension, but all 3 patients had no clinical symptoms and none had CHS. CHP occurred in 2/25 patients (8%) in the edaravone group and in 1/26 patients in the control group (4%), with no significant difference between the groups (P = 0.610).
Results date posted
| 2021 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of a total of 92 consecutive patients who underwent CAS at our department, 40 were excluded from the analysis owing to unmet inclusion criteria or refusal to participate. The remaining 52 patients were randomized 1:1 to receive pretreatment with edaravone (n = 26) or no edaravone (n = 26) before CAS
Participant flow
Assessed for eligibility (n=92)
Randomized (n=52)
Allocated to the edaravone group (n=26)
Allocated to the control group (n=26)
Analyzed (n=25)
Analyzed (n=26)
Adverse events
None
Outcome measures
The primary outcome was occurrence of CHP immediately after CAS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006297
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