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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040408
Receipt No. R000046114
Scientific Title Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg: multicenter registration survey
Date of disclosure of the study information 2020/05/16
Last modified on 2020/05/15

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Basic information
Public title Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg: multicenter registration survey
Acronym THAWS 2
Scientific Title Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg: multicenter registration survey
Scientific Title:Acronym THAWS 2
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of MRI-guided IV rt-PA for unknown onset stroke in clinical practice, comparing with WAKE-UP trial and THAWS trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes symptomatic intracranial hemorrhage within 36 hours after IV rt-PA.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with stroke symptoms with unknown time of onset
Admitted >4.5 hours since last-known-well and within 4.5 hours after symptom recognition.
No marked signal change on MRI FLAIR.
Key exclusion criteria Contraindication of IV rt-PA.
Contraindication of MRI.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Koga
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code 5648565
Address 6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
TEL 0661701070
Email koga@ncvc.go.jp

Public contact
Name of contact person
1st name Sohei
Middle name
Last name Yoshimura
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code 564-8565
Address 6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
TEL 0661701070
Homepage URL https://thaws.stroke-ncvc.jp/
Email sohei-y@ncvc.go.jp

Sponsor
Institute Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Agency of Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, National Cerebral and Cardiovascular Center
Address 6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
Tel 0661701070
Email rec-office-ac@ncvc.go.jp

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 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)、岩手県立中央病院(岩手県)、広南病院(宮城県)、山形市立病院済生館(山形県)、新潟市民病院(新潟県)、美原記念病院(群馬県)、日本医科大学(東京都)、順天堂大学医学部附属浦安病院(千葉県)東京慈恵会医科大学附属病院(東京都)、虎の門病院(東京都)、杏林大学(東京都)、武蔵野赤十字病院(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)、聖マリアンナ医科大学東横病院(神奈川県)、藤田保健衛生大学(愛知県)、東海大学医学部(神奈川県)、北里大学(東京都)、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)、国立病院機構京都医療センター(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)、山陰労災病院(鳥取県)、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)、佐賀大学(佐賀県)、長崎大学(長崎県)、済生会熊本病院(熊本県)、熊本赤十字病院 (熊本県)、国立病院機構鹿児島医療センター(鹿児島県)、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
2020 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 No longer recruiting
Date of protocol fixation
2019 Year 08 Month 15 Day
Date of IRB
2019 Year 10 Month 23 Day
Anticipated trial start date
2019 Year 10 Month 23 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 05 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information Patients treated from 2019/3/27 to 2020/3/31 are included. Max follow-up period is 6 montths.

Management information
Registered date
2020 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046114

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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