UMIN-CTR Clinical Trial

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

Acute ischemic stroke

Classification by specialty

Neurology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Neurology, Nippon Medical School

Institute

Department

Personal name

Organization

Department of Stroke medicine, Kawasaki medical school

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2011

Year

09

Month

12

Day

Last modified on

2017

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007504