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Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial

Chunjuan Wang, Hong-Qiu Gu, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Feng Wang, Yongjun Wang
DOI: 10.1136/svn-2023-002938 Published 11 March 2024
Chunjuan Wang
1China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
2Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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  • ORCID record for Chunjuan Wang
Hong-Qiu Gu
1China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
2Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Qiang Dong
3Department of Neurology, Huashan Hospital, Fudan University, Shanghai, Shanghai, China
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Anding Xu
4Department of Neurology, The First Affiliated Hospital of Jinan University, Guangzhou, China
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Ning Wang
5Department of Neurology, The First Affiliated Hospital, Institute of Neuroscience, Fujian Medical University, Fuzhou, China
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Yi Yang
6Department of Neurology, The First Hospital of Jilin University, Changchun, China
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Feng Wang
7State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China
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Yongjun Wang
1China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
2Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
8Vascular Neurology, Department of Neurology, Beijing Tiantan Hospital, Beijing, China
9Chinese Institute for Brain Research, Beijing, China
10Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences, Beijing, China
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    Figure 1

    TASTE-2 study design. EVT, endovascular therapy; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; TASTE-2, Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II.

  • Figure 2
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    Figure 2

    The inclusion and exclusion criteria of the TASTE-2 trial. TASTE-2, Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II.

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    The assessment flow chart

    Procedure/investigationBaselineFollow-up 1Follow-up 2Follow-up 3Follow-up 4
    Before randomisationThe day of randomisation1st day after randomisation (24±12 hours)14th day after randomisation or at discharge*90±7th day after randomisation
    Acquiring informed consentx
    Demographic informationx
    Medical historyx
    Prior medicationx
    Physical examinationxxxx
    NIHSSxxx
    mRSX†xx
    ECGx
    Laboratory testX‡
    Urine pregnancy testx
    Non-contrast CT/DWI (ADC)xx
    CTA/MRA/DSAx§
    CTP/MRPx¶
    Inclusion/exclusion criteria checkx
    Randomisationx
    Blood samplexx
    Drug deliveryx**
    EVTx
    Medication adherencex
    AE/SAExxxx
    Concomitant medicationxx
    • *If patient has not been discharged on the 14th day after randomisation, record the information on day 14th, if discharged before the day, record the information on the day of discharge. The interventional drug treatment duration is at least 10 days, so the discharge day should not be earlier than the 10th day after randomisation.

    • †Indicates the prior stroke modified Rankin Scale.

    • ‡Includes blood routine test, blood biochemistry (at least ALT, AST, serum creatinine/estimated glomerular filtration rate, fast glucose, electrolytes) and coagulation profile.

    • §At least one categories of angiography (CTA or MRA or DSA) was performed at baseline to certify the location of large vessel occlusion in the anterior circulation.

    • ¶For patients within 6–16 hours of symptom onset, the baseline screening image should contain CT+CTA+CTP or DWI+ADC+MRA+MRP (based on the DEFUSE-3 criteria: an infarct core <70 mL, a mismatch volume >15 mL and a mismatch ratio >1.8). For those within 16–24 hours of symptom onset, it should contain CT+CTA+CTP, or DWI+ADC+MRA (based on the DAWN criteria: an NIHSS score ≥10 with an infarct core volume <31 cm3, or an NIHSS score ≥20 with an infarct core volume ≤51 cm3). CT perfusion or MR diffusion and perfusion scans were evaluated by using an automatic software.

    • **Interventional drugs should be delivered after randomisation but ahead of EVT.

    • ADC, apparent diffusion coefficient; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate transaminase; CTA, CT angiography; CTP, CT perfusion; DSA, digital subtraction angiography; DWI, diffusion-weighted imaging; EVT, endovascular therapy; MRA, MR angiography; MRP, MR perfusion; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; SAE, serious AE.

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Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial
Chunjuan Wang, Hong-Qiu Gu, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Feng Wang, Yongjun Wang
Stroke and Vascular Neurology Mar 2024, svn-2023-002938; DOI: 10.1136/svn-2023-002938

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Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial
Chunjuan Wang, Hong-Qiu Gu, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Feng Wang, Yongjun Wang
Stroke and Vascular Neurology Mar 2024, svn-2023-002938; DOI: 10.1136/svn-2023-002938
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Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial
Chunjuan Wang, Hong-Qiu Gu, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Feng Wang, Yongjun Wang
Stroke and Vascular Neurology Mar 2024, svn-2023-002938; DOI: 10.1136/svn-2023-002938
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