Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study
Background Tenecteplase, a bioengineered variant of alteplase, is a new alternative thrombolytic agent. The ORIGINAL study aims to evaluate the efficacy and safety of tenecteplase versus standard care in Chinese patients with acute ischemic stroke within 4.5 hours of symptom onset. Methods This is a...
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Wiley
2024-07-01
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| Series: | Stroke: Vascular and Interventional Neurology |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/SVIN.124.001363 |
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| author | Xia Meng Shuya Li Hongguo Dai Guozhi Lu Weiwei Wang Fengyuan Che Yu Geng Minghui Sun Xiyan Li Yongjun Wang |
| author_facet | Xia Meng Shuya Li Hongguo Dai Guozhi Lu Weiwei Wang Fengyuan Che Yu Geng Minghui Sun Xiyan Li Yongjun Wang |
| author_sort | Xia Meng |
| collection | DOAJ |
| description | Background Tenecteplase, a bioengineered variant of alteplase, is a new alternative thrombolytic agent. The ORIGINAL study aims to evaluate the efficacy and safety of tenecteplase versus standard care in Chinese patients with acute ischemic stroke within 4.5 hours of symptom onset. Methods This is a multicenter phase III study that employs a randomized (1:1), active‐controlled, parallel‐group, prospective, open‐label, blinded–end point design. Adult participants (aged ≥18 years) with acute ischemic stroke who are eligible for intravenous thrombolysis within 4.5 hours of symptom onset according to current guideline recommendations are recruited from ≈55 neurology clinics/stroke centers throughout China. Results The primary objective of the ORIGINAL study is to demonstrate the noninferiority of tenecteplase (0.25 mg/kg) to alteplase (0.9 mg/kg) on the basis of the proportion of patients who achieve a modified Rankin Scale score of 0 or 1 on day 90, that is, a favorable functional outcome. The prespecified noninferiority risk ratio margin is 0.937. Secondary end points include other functional outcomes and the following safety end points: adjudicated symptomatic intracerebral hemorrhage (up to 36 hours after the end of study drug administration) based on the European Cooperative Acute Stroke Study III definition; all‐cause death within 90 days; and the proportion of patients with a modified Rankin Scale score of 5 or 6 on day 90. Conclusions It is anticipated that the results of this study will contribute to the growing body of evidence for the noninferiority of tenecteplase to alteplase given within 4.5 hours of acute ischemic stroke symptom onset and support a new indication for tenecteplase in China. Clinical Trial Registration Information NCT04915729 (https://clinicaltrials.gov/study/NCT04915729) |
| format | Article |
| id | doaj-art-a65a6abe728045b8a7dc4c4b97cd4d97 |
| institution | DOAJ |
| issn | 2694-5746 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stroke: Vascular and Interventional Neurology |
| spelling | doaj-art-a65a6abe728045b8a7dc4c4b97cd4d972025-08-20T03:07:46ZengWileyStroke: Vascular and Interventional Neurology2694-57462024-07-014410.1161/SVIN.124.001363Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL StudyXia Meng0Shuya Li1Hongguo Dai2Guozhi Lu3Weiwei Wang4Fengyuan Che5Yu Geng6Minghui Sun7Xiyan Li8Yongjun Wang9Department of Neurology and Department of Clinical Trial Center Beijing Tiantan Hospital, Capital Medical University Beijing ChinaDepartment of Neurology and Department of Clinical Trial Center Beijing Tiantan Hospital, Capital Medical University Beijing ChinaDepartment of Emergency Linfen Central Hospital Linfen ChinaDepartment of Neurology Hexigten Banner Mongolian Traditional Chinese Medicine Hospital Chifeng ChinaDepartment of Neurology Xianyang Hospital of Yan'an University Xianyang ChinaDepartment of Neurology Linyi People's Hospital Linyi ChinaCenter for Rehabilitation Medicine, Department of Neurology Zhejiang Provincial People's Hospital Hangzhou ChinaBoehringer Ingelheim (China) Investment Co., Ltd Shanghai ChinaBoehringer Ingelheim (China) Investment Co., Ltd Shanghai ChinaDepartment of Neurology and Department of Clinical Trial Center Beijing Tiantan Hospital, Capital Medical University Beijing ChinaBackground Tenecteplase, a bioengineered variant of alteplase, is a new alternative thrombolytic agent. The ORIGINAL study aims to evaluate the efficacy and safety of tenecteplase versus standard care in Chinese patients with acute ischemic stroke within 4.5 hours of symptom onset. Methods This is a multicenter phase III study that employs a randomized (1:1), active‐controlled, parallel‐group, prospective, open‐label, blinded–end point design. Adult participants (aged ≥18 years) with acute ischemic stroke who are eligible for intravenous thrombolysis within 4.5 hours of symptom onset according to current guideline recommendations are recruited from ≈55 neurology clinics/stroke centers throughout China. Results The primary objective of the ORIGINAL study is to demonstrate the noninferiority of tenecteplase (0.25 mg/kg) to alteplase (0.9 mg/kg) on the basis of the proportion of patients who achieve a modified Rankin Scale score of 0 or 1 on day 90, that is, a favorable functional outcome. The prespecified noninferiority risk ratio margin is 0.937. Secondary end points include other functional outcomes and the following safety end points: adjudicated symptomatic intracerebral hemorrhage (up to 36 hours after the end of study drug administration) based on the European Cooperative Acute Stroke Study III definition; all‐cause death within 90 days; and the proportion of patients with a modified Rankin Scale score of 5 or 6 on day 90. Conclusions It is anticipated that the results of this study will contribute to the growing body of evidence for the noninferiority of tenecteplase to alteplase given within 4.5 hours of acute ischemic stroke symptom onset and support a new indication for tenecteplase in China. Clinical Trial Registration Information NCT04915729 (https://clinicaltrials.gov/study/NCT04915729)https://www.ahajournals.org/doi/10.1161/SVIN.124.001363alteplaseChinesefunctional outcomeischemic strokesymptomatic intracerebral hemorrhagetenecteplase |
| spellingShingle | Xia Meng Shuya Li Hongguo Dai Guozhi Lu Weiwei Wang Fengyuan Che Yu Geng Minghui Sun Xiyan Li Yongjun Wang Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study Stroke: Vascular and Interventional Neurology alteplase Chinese functional outcome ischemic stroke symptomatic intracerebral hemorrhage tenecteplase |
| title | Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study |
| title_full | Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study |
| title_fullStr | Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study |
| title_full_unstemmed | Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study |
| title_short | Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study |
| title_sort | tenecteplase versus alteplase in acute ischemic stroke in chinese patients protocol for the original study |
| topic | alteplase Chinese functional outcome ischemic stroke symptomatic intracerebral hemorrhage tenecteplase |
| url | https://www.ahajournals.org/doi/10.1161/SVIN.124.001363 |
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