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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006330
Receipt No. R000007504
Scientific Title tissue type plasminogen activator(t-PA) and Edaravon combination therapy study
Date of disclosure of the study information 2011/12/10
Last modified on 2017/03/21

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Basic information
Public title tissue type plasminogen activator(t-PA) and Edaravon combination therapy study
Acronym YAMATO study
Scientific Title tissue type plasminogen activator(t-PA) and Edaravon combination therapy study
Scientific Title:Acronym YAMATO study
Region
Japan

Condition
Condition Acute ischemic stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the recanalization rate will be enhanced with the early administration of edaravone, a free radical scavenger, during intravenous tissue plasminogen activator (t-PA) infusion in acute stroke patients - multiple stroke center trial-
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Recanalization within one hour after t-PA infusion
Key secondary outcomes (1)Recanalization over 50% within one hour after t-PA infusion
(2)Complete recanalization within one hour after t-PA infusion
(3)Clinical outcome at 3 months after onset. We defined favorable outcomes as an modified Rankin scale (mRS) score of 0-2.
(4)Clinical improvement and deterioration after 1 h, 24 h, and 5-7 days. Dramatic recovery was defined as a 10-point and over reduction in total National Institutes of Health Stroke Scale (NIHSS) score or a total NIHSS score of 0 or 1. Good recovery was a 4-point and over reduction in total NIHSS score, excluding dramatic recovery. No change was from a 3-point increase to a 3-point reduction in total NIHSS score. Worsening was a 4-point and over increase in total NIHSS sore.
(5)Symptomatic cerebral hemorrhage at 1 h, 24 h, and 5-7 days, defined as an increase in NIHSS score of 4 and over

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Edaravone is administered before or at the same time with t-PA infusion
Interventions/Control_2 Edaravone is administered after the assessment of the presence of recanalization.
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 who can be treated with edaravone within 3 h of onset (When the Japanese guideline of the t-PA infusion permits the t-PA infusion in patients within within 4.5h of onset, this criteria will be automatically modefied to include patietns within 4.5 of onset.)
(2)Patients with horizontal or silvian portion of middle cerebral artery (MCA, M1 and M2) occlusion.
(3)All patients or their family provided a written Institutional Review Board-approved informed consent.
(4)Other inclusion criteria are similar to the Japanese guidelin of the t-PA infusion.
Key exclusion criteria (1)Patients with large infarcts on initial diffusion-weighted imaging (DWI) were excluded, using a DWI Alberta Stroke Programme Early computed tomography score (DWI-ASPECTS) of 4 and under to define large infarcts.
(2)Patients with internal carotid artery occlusion.
(3)Patients diagniosed as having bilateral symptomatic MCA occlusion.
(4)Patients with serum concentration of creatinine over 1.5mg/dl
(5)Patients who cannot be exmined using Magnetic resonance imaging.
(6)Patients who is and is suspected to be pregnant
(7)Patients with contraindication to the use of edaravone and to the Japanese guidelin of the t-PA infusion.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Aoki
Organization Nippon Medical School
Division name Neurology
Zip code
Address 1-1-5, Sendagi, Bunko-ku, Tokyo, Japan
TEL 03-3822-2131
Email j-aoki@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Aoki
Organization Nippon Medical School
Division name Neurology
Zip code
Address 1-1-5, Sendagi, Bunko-ku, Tokyo, Japan
TEL 03-3822-2131
Homepage URL http://www.nms.ac.jp/yamato/
Email j-aoki@nms.ac.jp

Sponsor
Institute Neurology, Nippon Medical School
Institute
Department

Funding Source
Organization Department of Stroke medicine, Kawasaki medical school
Organization
Division
Category of Funding Organization Self funding
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 徳島大学病院(徳島県)、川崎医科大学附属病院・付属川崎病院(岡山県)、順天堂大学医学部附属浦安病院(千葉県)、済生会熊本病院(熊本県)、製鉄記念八幡病院(福岡県)、神戸市立医療センター中央市民病院(兵庫県)、弘前脳卒中・リハビリテーションセンター(青森県)、岡山赤十字病院(岡山県)、福井県済生会病院(福井県)、長崎大学病院(長崎県)、横浜栄共済病院(神奈川県)、慈恵会医科大学(東京都)、神鋼病院(神戸)、沖縄協同病院(沖縄)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://stroke.ahajournals.org/content/48/3/712.long
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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 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 09 Month 12 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007504

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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