Evidence map›Paper›PMID 32248771›Full record

Trial reportStroke2020

Thrombolysis With Alteplase at 0.6 mg/kg for Stroke With Unknown Time of Onset: A Randomized Controlled Trial.

Masatoshi Koga, Haruko Yamamoto, Manabu Inoue, Koko Asakura, Junya Aoki, Toshimitsu Hamasaki, Takao Kanzawa, Rei Kondo, Masafumi Ohtaki, Ryo Itabashi and 33 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 14 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  4. Guideline
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  7. Outcomes of wake-up stroke undergoing mechanical thrombectomy: A systematic review and meta-analysis.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2024
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  14. Efficacy and Safety of Intravenous Thrombolytics in Ischemic Stroke Beyond the 4.5-Hour Time Window: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  15. Article
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  19. Development of tenecteplase for stroke thrombolysis: Japan's endeavor.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

43 authors.

Masatoshi KogaFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Haruko YamamotoCenter for Advancing Clinical and Translational Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita.
Manabu InoueFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Koko AsakuraDepartment of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.
Junya AokiDepartment of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).
Toshimitsu HamasakiDepartment of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.
Takao KanzawaDepartment of Stroke Medicine, Institute of Brain and Blood Vessels, Mihara Memorial Hospital, Isesaki (T. Kanzawa).
Rei KondoDepartment of Neurosurgery, Yamagata City Hospital Saiseikan (R. Kondo).
Masafumi OhtakiDepartment of Neurosurgery, Obihiro Kosei Hospital (M. Ohtaki).
Ryo ItabashiDepartment of Stroke Neurology, Kohnan Hospital, Sendai (R.I.).
Kenji KamiyamaDepartment of Neurosurgery, Nakamura Memorial Hospital, Sapporo (K. Kamiyama).
Toru IwamaDepartment of Neurosurgery, Gifu University School of Medicine (T. Iwama).
Taizen NakaseDepartment of Stroke Science, Research Institute for Brain and Blood Vessels, Akita (T.N.).
Yusuke YakushijiDivision of Neurology, Department of Internal Medicine, Saga University Faculty of Medicine (Y.Y.).
Shuichi IgarashiDepartment of Neurology, Niigata City General Hospital (S.I.).
Yoshinari NagakaneDepartment of Neurology, Kyoto Second Red Cross Hospital (Y.N.).
Shunya TakizawaDivision of Neurology, Department of Internal Medicine, Tokai University School of Medicine, Isehara (S.T.).
Yasushi OkadaDepartment of Cerebrovascular Medicine and Neurology, Cerebrovascular Center, National Hospital Organization Kyushu Medical Center, Fukuoka (Y.O.).
Ryosuke DoijiriDepartment of Neurology, Iwate Prefectural Central Hospital, Morioka (R.D.).
Akira TsujinoDepartment of Neurology and Strokology, Nagasaki University Graduate School of Biomedical Sciences (A.T.).
Yasuhiro ItoDepartment of Neurology, Toyota Memorial Hospital (Y.I.).
Hideyuki OhnishiDepartment of Neurosurgery, Ohnishi Neurological Center, Akashi (H.O.).
Takeshi InoueDepartment of Stroke Medicine, Kawasaki Medical School General Medical Center, Okayama (T. Inoue).
Yasushi TakagiDepartment of Neurosurgery, Tokushima University (Y.T.).
Yasuhiro HasegawaDepartment of Neurology, St. Marianna University School of Medicine, Kawasaki (Y.H.).
Yoshiaki ShiokawaDepartment of Neurosurgery, Kyorin University School of Medicine, Mitaka (Y.S.).
Nobuyuki SakaiDepartment of Neurosurgery, Kobe City Medical Center General Hospital (N.S.).
Masato OsakiDepartment of Cerebrovascular Medicine, Stroke Center, Steel Memorial Yawata Hospital, Kitakyushu (M.O.).
Yoshikazu UesakaDepartment of Neurology, Toranomon Hospital, Tokyo (Y.U.).
Shinichi YoshimuraDepartment of Neurosurgery, Hyogo College of Medicine, Nishinomiya (S. Yoshimura).
Takao UrabeDepartment of Neurology, Juntendo University Urayasu Hospital (T. Urabe).
Toshihiro UedaDepartment of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki (T. Ueda).
Masafumi IharaDepartment of Neurology (M. Ihara), National Cerebral and Cardiovascular Center, Suita.
Takanari KitazonoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka (T. Kitazono).
Makoto SasakiInstitute for Biomedical Sciences, Iwate Medical University, Yahaba (M.S.).
Akira OitaDepartment of Pharmacy (A.O.), National Cerebral and Cardiovascular Center, Suita.
Sohei YoshimuraFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Mayumi Fukuda-DoiFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Kaori MiwaFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Kazumi KimuraDepartment of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).
Kazuo MinematsuFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
Kazunori ToyodaFrom the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).
THAWS Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Purpose- We assessed whether lower-dose alteplase at 0.6 mg/kg is efficacious and safe for acute fluid-attenuated inversion recovery-negative stroke with unknown time of onset. Methods- This was an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke). Patients were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging showed acute ischemic lesion on diffusion-weighted imaging and no marked corresponding hyperintensity on fluid-attenuated inversion recovery. The primary outcome was a favorable outcome (90-day modified Rankin Scale score of 0-1). Results- Following the early stop and positive results of the WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke), this trial was prematurely terminated with 131 of the anticipated 300 patients (55 women; mean age, 74.4±12.2 years). Favorable outcome 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];

Indexed as

Time-to-TreatmentAgedAged, 80 and overDiffusion Magnetic Resonance ImagingDose-Response Relationship, DrugFemaleFibrinolytic AgentsHumansIntracranial HemorrhagesMaleMiddle AgedStrokeThrombolytic TherapyTissue Plasminogen ActivatorTreatment OutcomeFibrinolytic AgentsTissue Plasminogen Activatorcontrol groupsinformed consentintracranial hemorrhagesmagnetic resonance imagingstroke, acutetissue-type plasminogen activator

Identifiers

PMID32248771
PMCPMC7185058

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.