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Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial

Shuya Li, Hong-Qiu Gu, Hongguo Dai, Guozhi Lu, Yongjun Wang
DOI: 10.1136/svn-2023-003035 Published 5 November 2024
Shuya Li
1 Department of Neurology, and Department of Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
2 China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Hong-Qiu Gu
1 Department of Neurology, and Department of Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Hongguo Dai
3 Department of Emergency, Linfen Central Hospital, Shanxi Province, China
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Guozhi Lu
4 Department of Neurology, Keshiketeng Banner Traditional Chinese Medicine Mongolian Medical Hospital, The Inner Mongolia autonomous region, China
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Yongjun Wang
1 Department of Neurology, and Department of Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Tables

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  • Table 1

    Trial assessment flow chart

    BaselineTreatmentFollow-up
    Visit V1V2V3 V4V5V6V7
    Day-visitD1 (−4.5 h to
    0 h)
    D1 (0 h)D2 (24 h ±2 h)D4 (72 h ±6 h)D8±l dD31±3 dD91±7 d
    Informed consentX
    Demographic dataX
    WeightX
    Medical historyX
    Inclusion/exclusion criteriaX
    Vital signsXXXXX X
    Physical examinationXX
    Brain CT/MRIXX
    Pregnancy testsX
    HaematologyXXX
    UrinalysisXX
    Stool routine testX
    Blood chemistryXXX
    Coagulation testXXX
    Finger blood glucose Testm X
    ECGXXX
    NIHSSXXX
    mRSX (prestroke)X X
    Barthel lndexX X
    RandomisationX
    AdministrationX
    Concomitant medicationsX
    ProcedureD1 (−4.5 h ±0 h)D1 (0 h)D2 (24 h ±2 h)D4 (72 h ±6 h)D8±l dD31±3 dD91±7 d
    Adverse eventsX
    • CT, computed tomographic; D, day/days; h, hour/hours; MRI, Magnetic Resonance Imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.

Supplementary Materials

  • Tables
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  • Supplementary data

    [svn-2023-003035supp001.pdf]

  • Supplementary data

    [svn-2023-003035supp002.pdf]

  • Supplementary data

    [svn-2023-003035supp003.pdf]

  • Supplementary data

    [svn-2023-003035supp004.pdf]

Additional Files

  • Tables
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  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    • Data supplement 1
    • Data supplement 2
    • Data supplement 3
    • Data supplement 4
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Stroke and Vascular Neurology: 9 (5)
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Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial
Shuya Li, Hong-Qiu Gu, Hongguo Dai, Guozhi Lu, Yongjun Wang
Stroke and Vascular Neurology Oct 2024, 9 (5) 568-573; DOI: 10.1136/svn-2023-003035

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Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial
Shuya Li, Hong-Qiu Gu, Hongguo Dai, Guozhi Lu, Yongjun Wang
Stroke and Vascular Neurology Oct 2024, 9 (5) 568-573; DOI: 10.1136/svn-2023-003035
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Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial
Shuya Li, Hong-Qiu Gu, Hongguo Dai, Guozhi Lu, Yongjun Wang
Stroke and Vascular Neurology Oct 2024, 9 (5) 568-573; DOI: 10.1136/svn-2023-003035
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