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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002512
Receipt No. R000003073
Scientific Title Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Date of disclosure of the study information 2009/12/01
Last modified on 2012/10/29

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Basic information
Public title Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Acronym Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Scientific Title Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Scientific Title:Acronym Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Region
Japan

Condition
Condition Iscemic stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the safety and efficacy of the combined therapy with intravenous recombinant tissue plasminogen activator (IV rt-PA) and edaravone differs in the time of edaravone administration in the acute ischemic stroke patients within 3 hours of onset.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical improvement
Hemorrhagic complication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Group A:Start of edaravone administration within 15 minutes after starting IV rt-PA

A single alteplase(rt-PA) dose of 0.6 mg/kg is administered intravenously, with 10% given as a bolus, followed by continuous infusion of the remainder over 1 hour. Patients were also given 30mg edaravone over 30 minutes twice a day for 7 days.
Interventions/Control_2 Group B:Start of edaravone administration within 15 minutes after administration IV rt-PA

Administration procedure is same as above mentioned.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients within 3 hours of onset time
2)Arterial lesion of anterior circulation on magnetic resonance angiography
Key exclusion criteria 1)Diffusion weighted imaging evidence of significant early ischemic change
2)Other exclusion criteria are same as Japan Alteplase Clinical Trial (J-ACT)
(stroke 2006;37:1810)
3)exclusion criteria of edaravone administraion mentioned in the package insert. Serume creatinine concentration over 1.5mg/dl
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Aoki
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address 577, Matsushima, Kurashiki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of stroke medicine, Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 16 Day
Last modified on
2012 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003073

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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