UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011630
Receipt No. R000011778
Scientific Title THrombolysis for Acute Wake-up and unclear-onset Strokes with alteplase at 0.6 mg/kg (THAWS) Trial
Date of disclosure of the study information 2013/09/09
Last modified on 2019/03/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title THrombolysis for Acute Wake-up and unclear-onset Strokes
with alteplase at 0.6 mg/kg (THAWS) Trial
Acronym THAWS Trial
Scientific Title THrombolysis for Acute Wake-up and unclear-onset Strokes
with alteplase at 0.6 mg/kg (THAWS) Trial
Scientific Title:Acronym THAWS Trial
Region
Japan

Condition
Condition acute ischemic stroke
Classification by specialty
Neurology Radiology Neurosurgery
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify efficacy and safety of intravenous thrombolysis for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of stroke onset
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Rankin Scale 0-1 at 90 days
Key secondary outcomes A prespecified ordinal analysis of the modified Rankin score at 90 days,
symptomatic intracranial hemorrhage within 24 h,
Infarct volume at 7 days,
Infarct volume growth at 7 days,
etc

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Intervention: intravenous rt-PA
Interventions/Control_2 Control: standard medical therapy including antithrombotics
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinical diagnosis of acute ischemic stroke with unknown time of symptom onset
Last known well without neurological symptoms >4.5 h of treatment initiation
Treatment can be initiated <4.5 h of symptom recognition
ASPECTS on DWI >5
No marked parenchymal hyperintensity on FLAIR
Baseline NIHSS >=2
Key exclusion criteria Prestroke mRS >1
Ineligible for IV rt-PA according to the Japanese guideline (J Stroke Cerebrovasc Dis. 2013 Jul;22:571-600)
Contraindication to MRI, etc
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koga
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka 565-8565, JAPA
TEL 06-6833-5012
Email toyoda@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koga
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka 565-8565, JAPA
TEL 06-6833-5012
Homepage URL http://thaws.stroke-ncvc.jp/
Email koga@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Charitable Trust Mihara Cerebrovascular Disorder Research Promotion Fund

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02002325
Org. issuing International ID_1 U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 帯広厚生病院(北海道)、中村記念病院(北海道)、秋田県立脳血管研究センター(秋田県)、山形市立病院済生館(山形県)、広南病院(宮城県)、新潟市民病院(新潟県)、美原記念病院(群馬県)、順天堂大学医学部附属浦安病院(千葉県)、杏林大学(東京都)、虎の門病院(東京都)、日本医科大学(東京)、東京慈恵会医科大学付属病院(東京都)、昭和大学藤が丘病院(神奈川県)、聖マリアンナ医科大学(神奈川県)、東海大学(神奈川県)、北里大学(神奈川県)、トヨタ記念病院(愛知県)、名古屋第二赤十字病院(愛知県)、岐阜大学(岐阜県)、京都第二赤十字病院(京都府)、兵庫医科大学(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、大西脳神経外科病院(兵庫県)、川崎医科大学(岡山県)、川崎医科大学附属川崎病院(岡山県)、徳島大学(徳島県)小倉記念病院(福岡県)、製鐵記念八幡病院(福岡県)、福岡赤十字病院(福岡県)、国立病院機構九州医療センター(福岡県)、長崎大学病院(長崎県)、済生会熊本病院(熊本県)、熊本赤十字病院(熊本県)、武蔵野赤十字病院(東京都)、岩手県立中央病院(岩手県)、国立病院機構京都医療センター(京都府)、聖マリアンナ医科大学東横病院(神奈川県)、佐賀大学(佐賀県)、山陰労災病院(鳥取県)、国立病院機構鹿児島医療センター(鹿児島県)、藤田保健衛生大学(愛知県)、国立循環器病研究センター(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 09 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/25088843?dopt=Abstract
Publication of results Unpublished

Result
URL related to results and publications https://thaws.stroke-ncvc.jp/
Number of participants that the trial has enrolled
Results
131 patients were enrolled until July 2018
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
2013 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2018 Year 09 Month 19 Day
Date of closure to data entry
2018 Year 12 Month 04 Day
Date trial data considered complete
2019 Year 01 Month 21 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 02 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011778


Contact us.