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The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.
The study will be a multicentre, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial (2 arm with 1:1 randomization) in patients with acute ischemic stroke due to basilar artery occlusion presenting to hospital within 24 hours of symptom onset.
Patients will be required to have complete or near-complete occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA), defined as 'potentially retrievable' thrombus in the basilar artery. Thrombectomy is permitted within 24 hours as part of standard care but is not mandatory.
Patients will be randomized to treatment with either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg within 4.5 hours from stroke onset) or intravenous tenecteplase (0.25mg/kg, maximum 25mg). Time of onset of symptoms is defined as described by the patient or witness; if unknown, it is considered to be the last time the patient was seen well. In patients presenting with mild (e.g. vertigo, dizziness, headache, diplopia, dysarthria) stuttering symptoms followed by sudden onset of clinical deterioration with decrease in conscious state or moderate to severe motor deficits, the time of deterioration in clinical state is taken as the estimated time of basilar artery occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase | Experimental | Intravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion |
|
| Best Practice (which may include intravenous Alteplase) | Active Comparator | Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) 0-1 or return to baseline mRS | The proportion of patients with Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2-3) at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) 0-2 or return to baseline mRS | Proportion of patients with Modified Rankin Scale (mRS) 0-2 or return to baseline mRS at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death). | 3 months |
| Modified Rankin Scale (mRS) 0-3 or return to baseline mRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Bruce Campbell, MD, PhD | University of Melbourne | Principal Investigator |
| Fana Alemseged, MD, PhD | University of Melbourne | Study Director |
| Yunyun Xiong, MD, PhD | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe County Traditional Chinese Medicine Hospital | Fuyang | Anhui | China | |||
| Lixin County People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41655588 | Derived | Xiong Y, Alemseged F, Cao Z, Schwamm LH, Zhang S, Parsons MW, Fisher M, Hao Y, Jin A, Yin J, Jiang Y, Che F, Wang L, Zhou L, Dai H, Zhao Y, Duan C, Wu S, Feng G, Zong L, Ye W, Wang Z, Xu Z, Wang H, Hao M, Ma Y, Meng X, Li H, Li Z, Wang Y, Liu L, Zhao X, Campbell BCV, Wang Y; TRACE-5 investigators. Tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial. Lancet. 2026 Feb 21;407(10530):763-772. doi: 10.1016/S0140-6736(25)02633-9. Epub 2026 Feb 5. | |
| 41151803 |
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|
| Best Practice (which may include intravenous Alteplase) | Drug | Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion |
|
|
Proportion of patients with Modified Rankin Scale (mRS) 0-3 or return to baseline mRS at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death). |
| 3 months |
| Ordinal analysis of the Modified Rankin Scale (mRS) | Ordinal analysis of the Modified Rankin Scale (mRS), merging category 5-6, at 3 months. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death). | 3 months |
| Early neurological improvement | Proportion of patients achieving early clinical improvement (reduction in acute - 72 hour National Institutes of Health Stroke Scale [NIHSS] score of ≥8 or 72 hour NIHSS 0-1). | 72 hours |
| Successful reperfusion | Proportion of patients with complete occlusion at baseline who achieve expanded Thrombolysis In Cerebral Infarction score (eTICI) 2b/3 on initial digital subtraction angiography (DSA) run prior to thrombectomy. | initial DSA run prior to thrombectomy |
| Symptomatic intracranial hemorrhage (sICH) | Proportion of patients with symptomatic intracranial hemorrhage (sICH) defined as local or remote parenchymal hemorrhage type 2 (PH2) on the 22-36 hours post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 hours, or leading to death. | 36 hours |
| All-cause mortality | All-cause mortality within 90 days. | 90 days |
| Severe disability or death | Proportion of patients with Modified Rankin Scale (mRS) 5-6 at 90 days (severe disability or death). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death). | 90 days |
| Clinical deterioration | Proportion of patients with partially occlusive thrombus at baseline who have clinical deterioration within 24 hours leading to further treatment (e.g. endovascular thrombectomy). | 24 hours |
| Vessel recanalization | Vessel recanalization rate evaluated by CT or MR angiography within 24+/-6 hours (if performed). | 24+/-6 hours |
| Haozhou |
| Anhui |
| China |
| Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| First People's Hospital of Tianshui | Tianshui | Gansu | China |
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | China |
| Heyuan People's Hospital | Heyuan | Guangdong | China |
| Huazhou People's Hospital | Huazhou | Guangdong | China |
| Shaoguan Qujiang District People's Hospital | Shaoguan | Guangdong | China |
| The Second Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| The Second People's Hospital of Guiyang | Guiyang | Guizhou | China |
| Qiandongnanzhou People's Hospital | Qiandongnan | Guizhou | China |
| Haikou People's Hospital | Haikou | Hainan | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | China |
| Qiu County People's Hospital | Handan | Hebei | China |
| The Second Hospital of Qinhuangdao | Qinhuangdao | Hebei | China |
| Tangshan Guye Traditional Chinese Medicine Hospital | Tangshan | Hebei | China |
| Qinghe County People's Hospital | Xingtai | Hebei | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| Hongxinglong Hospital of Beidahuang Group | Shuangyashan | Heilongjiang | China |
| Huaxian People's Hospital of Henan | Anyang | Henan | China |
| Jiaozuo Coal Industry Central Hospital | Jiaozuo | Henan | China |
| The First People Hospital of Lingbao | Lingbao | Henan | China |
| Liuyang Jili Hospital | Liuyang | Henan | China |
| Nanshi Hospital of Nanyang | Nanyang | Henan | China |
| Nanle County People's Hospital | Puyang | Henan | China |
| Nanle Zhongxing Hospital | Puyang | Henan | China |
| Puyang Oilfield General Hospital | Puyang | Henan | China |
| Guangshan County People's Hospital | Xinyang | Henan | China |
| Xi County People's Hospital | Xinyang | Henan | China |
| Taikang Xian People's Hospital | Zhoukou | Henan | China |
| People's Hospital of Queshan | Zhumadian | Henan | China |
| Zhumadian Traditional Chinese Medicine Hospital | Zhumadian | Henan | China |
| Chenzhou First People's Hospital | Chenzhou | Hunan | China |
| The Fourth People's Hospital of Chenzhou | Chenzhou | Hunan | China |
| Hengyang Central Hospital | Hengyang | Hunan | China |
| Keshketeng Banner Chinese-Mongolian Hospital | Keshketeng Banner | Inner Mongolia | China |
| Tongliao People's Hospital | Tongliao | Inner Mongolia | China |
| Jiujiang First People's Hospital | Jiujiang | Jiangxi | China |
| Jilin Electric Power Hospital | Changchun | Jilin | China |
| Siping City Central People's Hospital | Siping | Jilin | China |
| Liuhe County People's Hospital | Tonghua | Jilin | China |
| The First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Liaoning | China |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | China |
| The Second People's Hospital of Dongying | Dongying | Shandong | China |
| Gaomi People's Hospital | Gaomi | Shandong | China |
| Laizhou City People's Hospital | Laizhou | Shandong | China |
| Linyi People's Hospital | Linyi | Shandong | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | China |
| The Second Affiliated Hospital of Shandong First Medical University | Taian | Shandong | China |
| The Affiliated Hospital of Shandong Second Medical University | Weifang | Shandong | China |
| Weifang People's Hospital | Weifang | Shandong | China |
| Weihai Central Hospital | Weihai | Shandong | China |
| Yantai Taochun Central Hospital | Yantai | Shandong | China |
| Zaozhuang Municipal Hospital | Zaozhuang | Shandong | China |
| Linfen Central Hospital | Linfen | Shanxi | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Ningbo Beilun District People's Hospital | Ningbo | Zhejiang | China |
| Beijing Daxing District People's Hospital | Beijing | China |
| Derived |
| Xiong Y, Alemseged F, Cao Z, Schwamm LH, Parsons M, Fisher M, Wu S, Campbell BCV, Wang Y. Tenecteplase versus standard care in patients with acute basilar artery occlusion: a multi-centre, prospective, randomised, open-label, blinded endpoint, phase 3, controlled trial. Stroke Vasc Neurol. 2025 Oct 28:svn-2025-004432. doi: 10.1136/svn-2025-004432. Online ahead of print. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| C104096 | TNK-tissue plasminogen activator |
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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