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Open Access

Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS)

Yao Lu, Ling Guan, Meiyang Zhang, Qianqian Yang, Baoshan Qiu, Dongyang Zhou, Yicong Wang, Yuesong Pan, Luyan Wang, Xuejiao Zhou, Hui Qu, Xiaoling Liao, Liping Liu, Xingquan Zhao, Philip M Bath, S Claiborne Johnston, Pierre Amarenco, Yongjun Wang, Yilong Wang
DOI: 10.1136/svn-2024-003577 Published 26 March 2025
Yao Lu
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Ling Guan
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
2The University of British Columbia Department of Medicine, Vancouver, British Columbia, Canada
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Meiyang Zhang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Qianqian Yang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Baoshan Qiu
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
4Chinese Institute for Brain Research, Beijing, China
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Dongyang Zhou
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
5Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
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Yicong Wang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Yuesong Pan
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Luyan Wang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Xuejiao Zhou
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Hui Qu
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Xiaoling Liao
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Liping Liu
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Xingquan Zhao
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Philip M Bath
6Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK
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S Claiborne Johnston
7Dell Medical School, The University of Texas at Austin, Austin, Texas, USA
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Pierre Amarenco
8Department of Neurology and Stroke Center, University Paris Cite, Paris, France
9Population Health Research Institute, McMaster University, Hamilton, New Zealand, Canada
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Yongjun Wang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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Yilong Wang
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
3China National Clinical Research Center for Neurological Diseases, Beijing, China
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    Figure 1

    The flow chart of Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke trial.

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  • Table 1

    Assessment schedule

    Screening and enrolmentTreatment and follow-up
    Visit 1Visit 2Visit 3Visit 4
    TimeBaseline24±2 hours after randomisation6±1 days after randomisation90±7 days after randomisation
    Informed consent×
    Inclusion/exclusion criteria×
    Demographics×
    Medical history×
    SARS-CoV-2 infection×××
    Physical examination×××
    Swallowing function evaluation××
    NIHSS×××
    mRS××
    EQ-5D×
    Reperfusion therapy evaluation×
    hs-CRP××
    Routine laboratory test×*׆
    Venous blood sample‡×××
    Cerebral haemodynamic function (single-centre)×××
    Outcome event×§××¶
    ECG×
    Primary diagnosis×
    Final diagnosis×
    Randomisation×
    Compliance××
    Drug dispense/retrieve×××
    AE/SAE×××
    Concomitant medication××××
    • *Routine blood counts, liver function, renal function, coagulation function and pregnancy test (for women of childbearing age) must be completed during screening.

    • †Results of routine blood counts, biochemical panels (including liver function, renal function, blood lipids, creatine kinase), glycosylated haemoglobin, homocysteine and coagulation function test should be recorded if completed in clinical.

    • ‡Venous blood samples will be collected, followed by the separation, packaging and freezing of plasma for storage.

    • §The assessment of outcome events at 24±2 hours and 6±1 days after randomisation included early neurological deterioration, stroke (ischaemic stroke and haemorrhagic stroke), myocardial infarction, death, symptomatic intracranial haemorrhage, any bleeding event, antibiotics-associated diarrhoea, enteritis and constipation.

    • ¶The assessment of outcome events at 90±7 days after randomisation included stroke (ischaemic and haemorrhagic strokes), myocardial infarction, death and any bleeding event.

    • AE, adverse event; EQ-5D, EuroQol-5 Dimension; hs-CRP, high-sensitivity C-reactive protein; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; SAE, serious adverse event.

Supplementary Materials

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    [svn-2024-003577supp001.pdf]

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Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS)
Yao Lu, Ling Guan, Meiyang Zhang, Qianqian Yang, Baoshan Qiu, Dongyang Zhou, Yicong Wang, Yuesong Pan, Luyan Wang, Xuejiao Zhou, Hui Qu, Xiaoling Liao, Liping Liu, Xingquan Zhao, Philip M Bath, S Claiborne Johnston, Pierre Amarenco, Yongjun Wang, Yilong Wang
Stroke and Vascular Neurology Mar 2025, svn-2024-003577; DOI: 10.1136/svn-2024-003577

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Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS)
Yao Lu, Ling Guan, Meiyang Zhang, Qianqian Yang, Baoshan Qiu, Dongyang Zhou, Yicong Wang, Yuesong Pan, Luyan Wang, Xuejiao Zhou, Hui Qu, Xiaoling Liao, Liping Liu, Xingquan Zhao, Philip M Bath, S Claiborne Johnston, Pierre Amarenco, Yongjun Wang, Yilong Wang
Stroke and Vascular Neurology Mar 2025, svn-2024-003577; DOI: 10.1136/svn-2024-003577
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Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS)
Yao Lu, Ling Guan, Meiyang Zhang, Qianqian Yang, Baoshan Qiu, Dongyang Zhou, Yicong Wang, Yuesong Pan, Luyan Wang, Xuejiao Zhou, Hui Qu, Xiaoling Liao, Liping Liu, Xingquan Zhao, Philip M Bath, S Claiborne Johnston, Pierre Amarenco, Yongjun Wang, Yilong Wang
Stroke and Vascular Neurology Mar 2025, svn-2024-003577; DOI: 10.1136/svn-2024-003577
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