Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial
Introduction Despite the implementation of mechanical thrombectomy, acute ischaemic stroke with large vessel occlusion (AIS-LVO) remains a significant health concern, characterised by substantial morbidity and mortality. Our trial aims to evaluate the efficacy and safety of minocycline in reducing i...
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BMJ Publishing Group
2024-12-01
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| author | Xiao Zhang Li Yao Jingjing Zhao Hao Zhu Bin Wang Huiping Zhang Wen Jiang Dong Wei Wen Liu Zhongqing Sun Weiwang Li Xiangjun Yuan Xingshun Ma Junpeng Meng Yi Jia Na Qin |
| author_facet | Xiao Zhang Li Yao Jingjing Zhao Hao Zhu Bin Wang Huiping Zhang Wen Jiang Dong Wei Wen Liu Zhongqing Sun Weiwang Li Xiangjun Yuan Xingshun Ma Junpeng Meng Yi Jia Na Qin |
| author_sort | Xiao Zhang |
| collection | DOAJ |
| description | Introduction Despite the implementation of mechanical thrombectomy, acute ischaemic stroke with large vessel occlusion (AIS-LVO) remains a significant health concern, characterised by substantial morbidity and mortality. Our trial aims to evaluate the efficacy and safety of minocycline in reducing infarct volume and improving functional outcomes in patients undergoing mechanical thrombectomy for anterior circulation AIS-LVO.Methods and analysis The MIST-A trial is a prospective, randomised, open-label, blinded-endpoint trial to be conducted across 12 medical centres. The study will enrol 180 adult patients who have experienced an anterior circulation AIS-LVO and have undergone mechanical thrombectomy. These patients will be randomly divided into two groups: one receiving minocycline in addition to standard care and the other receiving only standard care. The primary efficacy outcome is the change in infarct volume as measured by MRI, from baseline to day 5. The secondary efficacy outcomes include the incidence of intracerebral haemorrhage occurring within 24 hours and the clinical scores between the baseline and follow-up assessments. The primary outcome will be assessed using a mixed-effects model to determine the association between treatment and outcomes.Ethics and dissemination The study is approved by the Ethics Committee of Xijing Hospital (XJLL-KY20222186) and is registered at ClinicalTrials.gov (NCT05487417). This trial is estimated to end in the first quarter of 2025 and study findings are expected to be published in scientific journals that undergo peer review and also to be showcased at scientific conferences.Trial registration number NCT05487417. |
| format | Article |
| id | doaj-art-5760ae587a374e79baeb8865b2c8c3fb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5760ae587a374e79baeb8865b2c8c3fb2025-01-14T09:35:13ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-093443Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trialXiao Zhang0Li Yao1Jingjing Zhao2Hao Zhu3Bin Wang4Huiping Zhang5Wen Jiang6Dong Wei7Wen Liu8Zhongqing Sun9Weiwang Li10Xiangjun Yuan11Xingshun Ma12Junpeng Meng13Yi Jia14Na Qin151 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China2 Department of Neurology, Xi`an XD Group Hospital, Xi`an, China1 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China4 Department of Neurology, First People`s Hospital of Xianyang, Xianyang, China10 Department of Neurology, Jingyang County Hospital, Xianyang, China6 Department of Neurology, Baoji High-Tech Hospital, Baoji, China1 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China1 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China5 Department of Neurology, Yan`an University Xianyang Hospital, Xianyang, China1 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China3 Department of Neurology, Xi`an Daxing Hospital, Xi`an, China7 Department of Neurology, Weinan Central Hospital, Weinan, China8 Department of Neurology, The First Hospital of Yulin, Yulin, China9 Department of Neurology, Northwest University First Hospital, Xi`an, China11 Department of Neurology, Xi`an Gaoxin Hospital, Xi`an, China12 Department of Neurology, The Second Affiliated Hospital of Xi`an Medical University, Xi`an, ChinaIntroduction Despite the implementation of mechanical thrombectomy, acute ischaemic stroke with large vessel occlusion (AIS-LVO) remains a significant health concern, characterised by substantial morbidity and mortality. Our trial aims to evaluate the efficacy and safety of minocycline in reducing infarct volume and improving functional outcomes in patients undergoing mechanical thrombectomy for anterior circulation AIS-LVO.Methods and analysis The MIST-A trial is a prospective, randomised, open-label, blinded-endpoint trial to be conducted across 12 medical centres. The study will enrol 180 adult patients who have experienced an anterior circulation AIS-LVO and have undergone mechanical thrombectomy. These patients will be randomly divided into two groups: one receiving minocycline in addition to standard care and the other receiving only standard care. The primary efficacy outcome is the change in infarct volume as measured by MRI, from baseline to day 5. The secondary efficacy outcomes include the incidence of intracerebral haemorrhage occurring within 24 hours and the clinical scores between the baseline and follow-up assessments. The primary outcome will be assessed using a mixed-effects model to determine the association between treatment and outcomes.Ethics and dissemination The study is approved by the Ethics Committee of Xijing Hospital (XJLL-KY20222186) and is registered at ClinicalTrials.gov (NCT05487417). This trial is estimated to end in the first quarter of 2025 and study findings are expected to be published in scientific journals that undergo peer review and also to be showcased at scientific conferences.Trial registration number NCT05487417.https://bmjopen.bmj.com/content/14/12/e093443.full |
| spellingShingle | Xiao Zhang Li Yao Jingjing Zhao Hao Zhu Bin Wang Huiping Zhang Wen Jiang Dong Wei Wen Liu Zhongqing Sun Weiwang Li Xiangjun Yuan Xingshun Ma Junpeng Meng Yi Jia Na Qin Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial BMJ Open |
| title | Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial |
| title_full | Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial |
| title_fullStr | Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial |
| title_full_unstemmed | Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial |
| title_short | Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial |
| title_sort | effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy mist a the study protocol for a multicentre prospective randomised open label blinded endpoint trial |
| url | https://bmjopen.bmj.com/content/14/12/e093443.full |
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