Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
- Conditions
- Ischemic Stroke, Acute
- Interventions
- Drug: Best Practice (which may include intravenous Alteplase)
- Registration Number
- NCT06196320
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
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.
- Detailed Description
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 partial 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 452
- Age ≥18.
- Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
- Presence of a basilar artery occlusion, proven by CT Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion.
- Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
- Local legal requirements for consent have been satisfied.
- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images<6.
- Significant cerebellar mass effect or acute hydrocephalus.
- Established frank hypodensity on non-contrast CT indicating subacute infarction.
- Bilateral extensive brainstem ischemia.
- Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
- Other standard contraindications to intravenous thrombolysis.
- Contraindication to imaging with contrast agents.
- Clinically evident pregnant women.
- Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
- Current participation in another research drug treatment protocol.
- Known terminal illness such that the patients would not be expected to survive a year.
- Planned withdrawal of care or comfort care measures.
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Best Practice (which may include intravenous Alteplase) Best Practice (which may include intravenous Alteplase) Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion Tenecteplase Tenecteplase Intravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion
- Primary Outcome Measures
Name Time Method Modified Rankin Scale (mRS) 0-1 or return to baseline mRS 3 months 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).
- Secondary Outcome Measures
Name Time Method All-cause mortality 90 days All-cause mortality within 90 days.
Modified Rankin Scale (mRS) 0-3 or return to baseline mRS 3 months 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).
Modified Rankin Scale (mRS) 0-2 or return to baseline mRS 3 months 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).
Early neurological improvement 72 hours 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).
Successful reperfusion initial DSA run prior to thrombectomy 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.
Severe disability or death 90 days 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).
Symptomatic intracranial hemorrhage (sICH) 36 hours Proportion of patients with Symptomatic intracranial hemorrhage (sICH) defined as parenchymal haemorrhage type 2 (PH2), subarachnoid haemorrhage, and/or intraventricular haemorrhage within 36 hours of treatment, combined with a neurological deterioration of ≥4 points on the NIHSS from baseline, or leading to death.
Vessel recanalization 24+/-6 hours Vessel recanalization rate evaluated by CT or MR angiography within 24+/-6 hours (if performed).
Ordinal analysis of the Modified Rankin Scale (mRS) 3 months 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).
Clinical deterioration 24 hours Proportion of patients with partially occlusive thrombus at baseline who have clinical deterioration within 24 hours leading to further treatment (e.g. endovascular thrombectomy).
Trial Locations
- Locations (59)
Yantai Taochun Central Hospital
🇨🇳Yantai, Shandong, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Taihe County Traditional Chinese Medicine Hospital
🇨🇳Fuyang, Anhui, China
Lixin County People's Hospital
🇨🇳Haozhou, Anhui, 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
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
Beijing Tian Tan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China