Unique ID issued by UMIN | UMIN000011630 |
---|---|
Receipt number | 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 | 2020/12/15 10:43:19 |
THrombolysis for Acute Wake-up and unclear-onset Strokes
with alteplase at 0.6 mg/kg (THAWS) Trial
THAWS Trial
THrombolysis for Acute Wake-up and unclear-onset Strokes
with alteplase at 0.6 mg/kg (THAWS) Trial
THAWS Trial
Japan |
acute ischemic stroke
Neurology | Radiology | Neurosurgery |
Emergency medicine |
Others
NO
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
Safety,Efficacy
modified Rankin Scale 0-1 at 90 days
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
Intervention: intravenous rt-PA
Control: standard medical therapy including antithrombotics
20 | years-old | <= |
Not applicable |
Male and Female
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
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
300
1st name | Masatoshi |
Middle name | |
Last name | Koga |
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
565-8565
5-7-1 Fujishirodai, Suita, Osaka 565-8565, JAPA
06-6833-5012
toyoda@ncvc.go.jp
1st name | Masatoshi |
Middle name | |
Last name | Koga |
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
565-8565
5-7-1 Fujishirodai, Suita, Osaka 565-8565, JAPA
06-6833-5012
http://thaws.stroke-ncvc.jp/
koga@ncvc.go.jp
National Cerebral and Cardiovascular Center
Japan Agency for Medical Research and Development
Other
Japan
Charitable Trust Mihara Cerebrovascular Disorder Research Promotion Fund
IRB, National Cerebral and Cardiovascular Center
5-7-1 Fujishirodai, Suita, Osaka
06-6833-5012
plandiv@ml.ncvc.go.jp
YES
NCT02002325
U.S. National Institutes of Health
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)
2013 | Year | 09 | Month | 09 | Day |
http://www.ncbi.nlm.nih.gov/pubmed/25088843?dopt=Abstract
Published
https://thaws.stroke-ncvc.jp/
131
131 patients were enrolled until July 2018.
Primary outcome: Favorable outcome (mRS 0-1) was comparable between the alteplase group (32/68, 47.1%) and the control group (28/58, 48.3%; relative risk (RR), 0.97 (95% CI, 0.68-1.41); P=0.892).
Safety outcomes: Symptomatic intracranial hemorrhage within 22 to 36 hours occurred in 1/71 and 0/60 (RR, infinity (95% CI, 0.06 to infinity); P>0.999), respectively. Death at 90 days occurred in 2/71 and 2/60 (RR, 0.85 (95% CI, 0.06-12.58); P>0.999), respectively.
2019 | Year | 03 | Month | 11 | Day |
2020 | Year | 04 | Month | 04 | Day |
Alteplase group (n=70): 73.2+/-12.4 years old, 25 females (36%), 53 wake-up strokes (76%), median initial NIHSS 7 (IQR 4-13), last known well to randomization time: median 10.2 hours (IQR 8.2-12.2)
Control group (n=61): 75.8+/-11.9 years old, 30 females (49%), 40 wake-up strokes (66%), median initial NIHSS 7 (IQR 5-12), last known well to randomization time: median 10.3 hours (IQR 7.7-11.8)
Following the early stop and positive results of the WAKE-UP trial, the THAWS steering committee suspended further enrollments on July 10, 2018. A total of 131 patients underwent randomization, as compared with the targeted enrollment of 300 patients. Of the 131 enrolled patients, 70 were assigned to the alteplase group and 61 to the control group
In the alteplase group, 9 patients (12.7%) experienced a serious adverse event, as compared with 6 patients (10%) in the control group (P=0.632).
Primary outcome: Favorable outcome (mRS 0-1) was comparable between the alteplase group (32/68, 47.1%) and the control group (28/58, 48.3%; relative risk (RR), 0.97 (95% CI, 0.68-1.41); P=0.892).
Safety outcomes: Symptomatic intracranial hemorrhage within 22 to 36 hours occurred in 1/71 and 0/60 (RR, infinity (95% CI, 0.06 to infinity); P>0.999), respectively. Death at 90 days occurred in 2/71 and 2/60 (RR, 0.85 (95% CI, 0.06-12.58); P>0.999), respectively.
Completed
2013 | Year | 11 | Month | 30 | Day |
2013 | Year | 05 | Month | 10 | Day |
2014 | Year | 05 | Month | 01 | Day |
2018 | Year | 09 | Month | 19 | Day |
2018 | Year | 12 | Month | 04 | Day |
2019 | Year | 01 | Month | 21 | Day |
2019 | Year | 03 | Month | 31 | Day |
PUBLICATIONS
1. Koga M, Yamamoto H, Inoue M, et al: Thrombolysis with alteplase at 0.6 mg/kg for stroke with unknown time of onset: a randomized controlled trial. Stroke. 2020;51(5):1530-1538. (main results)
2. Toyoda K, Inoue M, Yoshimura S, et al: Magnetic Resonance Imaging-Guided Thrombolysis (0.6 mg/kg) Was Beneficial for Unknown Onset Stroke Above a Certain Core Size: THAWS RCT Substudy. Stroke. 2020 Dec 10:STROKEAHA120030848. doi: 10.1161/STROKEAHA.120.030848. Online ahead of print. (subanalysis)
3. Thomalla G, Boutitie F, Ma H, Koga M, et al: Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data. Lancet. 2020 Nov 14;396(10262):1574-1584 (IPD meta-analysis including THAWS)
2013 | Year | 09 | Month | 02 | Day |
2020 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011778
Research Plan | |
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Registered date | File name |
2020/12/15 | THAWS,Protocol,IJS2014.pdf |
Research case data specifications | |
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Research case data | |
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