Rohit Bhatia, MV Padma Srivastava, Saman Fatima, Risha Sarkar, Imnameren Longkumer, Shailesh Gaikwad, Leve S Joseph Devaranjan, Ajay Garg, Jeyaraj Durai Pandian, Dheeraj Khurana, PN Sylaja, Shweta Jain, Deepti Arora, Aneesh Dhasan, Sanjith Aaron, Angel T Miraclin, Pamidimukkala Vijaya, Srijithesh P Rajendran, Jayanta Roy, Biman Kanti Ray, Vivek Nambiar, Paul J Alapatt, Meenakshi Sharma
{"title":"RE-OPEN:在大血管闭塞导致的急性缺血性中风的血管内治疗中,生物类似物 TNK 与 TPA 的随机试验","authors":"Rohit Bhatia, MV Padma Srivastava, Saman Fatima, Risha Sarkar, Imnameren Longkumer, Shailesh Gaikwad, Leve S Joseph Devaranjan, Ajay Garg, Jeyaraj Durai Pandian, Dheeraj Khurana, PN Sylaja, Shweta Jain, Deepti Arora, Aneesh Dhasan, Sanjith Aaron, Angel T Miraclin, Pamidimukkala Vijaya, Srijithesh P Rajendran, Jayanta Roy, Biman Kanti Ray, Vivek Nambiar, Paul J Alapatt, Meenakshi Sharma","doi":"10.1136/bmjno-2023-000531","DOIUrl":null,"url":null,"abstract":"Rationale Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy. Aim The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO. Sample size estimates Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study. Methods and design This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design. Study outcomes The primary outcomes include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. Secondary outcomes include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. Safety outcomes include any intracranial bleeding or symptomatic ICH. Discussion This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK. Trial registration number CTRI/2022/01/039473.","PeriodicalId":52754,"journal":{"name":"BMJ Neurology Open","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions\",\"authors\":\"Rohit Bhatia, MV Padma Srivastava, Saman Fatima, Risha Sarkar, Imnameren Longkumer, Shailesh Gaikwad, Leve S Joseph Devaranjan, Ajay Garg, Jeyaraj Durai Pandian, Dheeraj Khurana, PN Sylaja, Shweta Jain, Deepti Arora, Aneesh Dhasan, Sanjith Aaron, Angel T Miraclin, Pamidimukkala Vijaya, Srijithesh P Rajendran, Jayanta Roy, Biman Kanti Ray, Vivek Nambiar, Paul J Alapatt, Meenakshi Sharma\",\"doi\":\"10.1136/bmjno-2023-000531\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Rationale Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy. Aim The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO. Sample size estimates Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study. Methods and design This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design. Study outcomes The primary outcomes include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. Secondary outcomes include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. Safety outcomes include any intracranial bleeding or symptomatic ICH. Discussion This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK. Trial registration number CTRI/2022/01/039473.\",\"PeriodicalId\":52754,\"journal\":{\"name\":\"BMJ Neurology Open\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Neurology Open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjno-2023-000531\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Neurology Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/bmjno-2023-000531","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions
Rationale Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy. Aim The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO. Sample size estimates Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study. Methods and design This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design. Study outcomes The primary outcomes include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. Secondary outcomes include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. Safety outcomes include any intracranial bleeding or symptomatic ICH. Discussion This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK. Trial registration number CTRI/2022/01/039473.