NCT06196320CompletedPhase 3
Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 452 (actual)
- First submitted
- 6 Dec 2023
- Start date
- 24 Jan 2024
- Primary completion date
- 11 Sept 2025
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT06196320
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 452
- From 24 Jan 2024 to the primary completion date, 11 Sept 2025
- 59 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
- Current participation in another research drug treatment protocol.
Other illness
- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) \<6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI).
- Known terminal illness such that the patients would not be expected to survive a year.
- 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.
Other
- Significant cerebellar mass effect or acute hydrocephalus.
- Established frank hypodensity on non-contrast CT indicating subacute infarction.
- Bilateral extensive brainstem ischemia.
- 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.
- Planned withdrawal of care or comfort care measures.
Who the study is looking for
- Age ≥18.
- Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete 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 or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (59)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huaxian People's Hospital of Henan Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| Beijing Daxing District People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tian Tan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Electric Power Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Chenzhou First People's Hospital Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| The Fourth People's Hospital of Chenzhou Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| The Second People's Hospital of Dongying Coordinator of this site? Confirm its status | Dongying | China | Unknown status |
| Taihe County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Fuyang | China | Unknown status |
| Gaomi People's Hospital Coordinator of this site? Confirm its status | Gaomi | China | Unknown status |
| Guangdong Second Provincial General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second People's Hospital of Guiyang Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| The Second Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Haikou People's Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Qiu County People's Hospital Coordinator of this site? Confirm its status | Handan | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Lixin County People's Hospital Coordinator of this site? Confirm its status | Haozhou | China | Unknown status |
| The 2nd Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Hengyang Central Hospital Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| Heyuan People's Hospital Coordinator of this site? Confirm its status | Heyuan | China | Unknown status |
| Huazhou People's Hospital Coordinator of this site? Confirm its status | Huazhou | China | Unknown status |
| Jiaozuo Coal Industry Central Hospital Coordinator of this site? Confirm its status | Jiaozuo | China | Unknown status |
| The First Affiliated Hospital of Jinzhou Medical University Coordinator of this site? Confirm its status | Jinzhou | China | Unknown status |
| Jiujiang First People's Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| Keshketeng Banner Chinese-Mongolian Hospital Coordinator of this site? Confirm its status | Keshketeng Banner | China | Unknown status |
| Laizhou City People's Hospital, Coordinator of this site? Confirm its status | Laizhou | China | Unknown status |
| Linfen Central Hospital Coordinator of this site? Confirm its status | Linfen | China | Unknown status |
| The first people hospital of lingbao Coordinator of this site? Confirm its status | Lingbao | China | Unknown status |
| Linyi People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Liuyang Jili Hospital Coordinator of this site? Confirm its status | Liuyang | China | Unknown status |
| Nanshi Hospital of Nanyang Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Ningbo Beilun District People's Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Nanle Zhongxing Hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| Nanle county people's hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| Puyang Oilfield General Hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| Qiandongnanzhou People's Hospital Coordinator of this site? Confirm its status | Qiandongnan | China | Unknown status |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| The Second Hospital of Qinhuangdao Coordinator of this site? Confirm its status | Qinhuangdao | China | Unknown status |
| Shaoguan Qujiang District People's Hospital Coordinator of this site? Confirm its status | Shaoguan | China | Unknown status |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Hongxinglong Hospital of Beidahuang Group Coordinator of this site? Confirm its status | Shuangyashan | China | Unknown status |
| Siping City Central People's Hospital Coordinator of this site? Confirm its status | Siping | China | Unknown status |
| The Second Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Taian | China | Unknown status |
| Tangshan Guye Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| First People's Hospital of Tianshui Coordinator of this site? Confirm its status | Tianshui | China | Unknown status |
| Liuhe County People's Hospital Coordinator of this site? Confirm its status | Tonghua | China | Unknown status |
| Tongliao People's Hospital Coordinator of this site? Confirm its status | Tongliao | China | Unknown status |
| The Affiliated Hospital of Shandong Second Medical University Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Weihai Central Hospital Coordinator of this site? Confirm its status | Weihai | China | Unknown status |
| Qinghe County People's Hospital Coordinator of this site? Confirm its status | Xingtai | China | Unknown status |
| Guangshan County People's Hospital Coordinator of this site? Confirm its status | Xinyang | China | Unknown status |
| Xi County People's Hospital Coordinator of this site? Confirm its status | Xinyang | China | Unknown status |
| Yantai Taochun Central Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
| Zaozhuang Municipal Hospital Coordinator of this site? Confirm its status | Zaozhuang | China | Unknown status |
| Taikang Xian People's Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Unknown status |
| Zhumadian Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| People's Hospital of Queshan Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.