Unique ID issued by UMIN | UMIN000040408 |
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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 |
Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg: multicenter registration survey
THAWS 2
Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg: multicenter registration survey
THAWS 2
Japan |
acute ischemic stroke
Cardiology | Neurology | Emergency medicine |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
symptomatic intracranial hemorrhage within 36 hours after IV rt-PA.
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
Observational
Not applicable |
Not applicable |
Male and Female
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.
Contraindication of IV rt-PA.
Contraindication of MRI.
50
1st name | Masatoshi |
Middle name | |
Last name | Koga |
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
5648565
6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
0661701070
koga@ncvc.go.jp
1st name | Sohei |
Middle name | |
Last name | Yoshimura |
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
564-8565
6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
0661701070
https://thaws.stroke-ncvc.jp/
sohei-y@ncvc.go.jp
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center
Japan Agency of Medical Research and Development
Japanese Governmental office
Japan
Research Ethics Committee, National Cerebral and Cardiovascular Center
6-1 Kisibe-shimmachi, Suita, Osaka JAPAN
0661701070
rec-office-ac@ncvc.go.jp
NO
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)
2020 | Year | 05 | Month | 16 | Day |
https://pubmed.ncbi.nlm.nih.gov/37263235/
Published
https://pubmed.ncbi.nlm.nih.gov/37263235/
66
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.
2023 | Year | 11 | Month | 20 | Day |
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.
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
Two patients (3%) had sICH.
sICH, all-cause death. NIHSS change, mRS at 90d
Main results already published
2019 | Year | 08 | Month | 15 | Day |
2019 | Year | 10 | Month | 23 | Day |
2019 | Year | 10 | Month | 23 | Day |
2020 | Year | 12 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 05 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
Patients treated from 2019/3/27 to 2020/3/31 are included. Max follow-up period is 6 montths.
2020 | Year | 05 | Month | 15 | Day |
2023 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046114
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