UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	tissue type plasminogen activator(t-PA) and Edaravon combination therapy study
Title of the study (Brief title)	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	Junya Aoki
Organization	Nippon Medical School
Division name	Neurology
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	Junya Aoki
Organization	Nippon Medical School
Division name	Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://stroke.ahajournals.org/content/48/3/712.long
Results
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/icdr_e/ctr_view.cgi?recptno=R000007504