UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040408
Receipt number 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 2023/11/20 12:27:28

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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

all-cause death within 90 days after stroke
90-day modified Rankin Scale score of 0-1
all adverse events within 90 days
NIHSS at 24h


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 or person

Institute

Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center

Institute

Department

Personal name



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

https://pubmed.ncbi.nlm.nih.gov/37263235/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/37263235/

Number of participants that the trial has enrolled

66

Results

Two patients (3%) had sICH. Median NIHSS changes from 11 at baseline to 5 at 24 h after IVT. At discharge, 31 patients (47%) had favourable outcome and 29 (44%) had complete indepndence. None died within 90d. 23 (35%) also underwent EVT, of whom 11 (48%) were completely independent at discharge.

Results date posted

2023 Year 11 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Acute ischemic stroke patients with last-known-well time more than 4.5 h who had mismatch between DWI and FLAIR and were treated with IV alteplase.

Participant flow

Acute ischemic stroke patients with last-known-well time >4.5 h who had mismatch between DWI and FLAIR and were treated with IV alteplase

Adverse events

Two patients (3%) had sICH.

Outcome measures

sICH, all-cause death. NIHSS change, mRS at 90d

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

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

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.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