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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

Full criteria on ClinicalTrials.gov

Sites (59)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Huaxian People's Hospital of Henan
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AnyangChinaUnknown status
Affiliated Hospital of Hebei University
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BaodingChinaUnknown status
Beijing Daxing District People's Hospital
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BeijingChinaUnknown status
Beijing Tian Tan Hospital, Capital Medical University
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BeijingChinaUnknown status
Jilin Electric Power Hospital
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ChangchunChinaUnknown status
Chenzhou First People's Hospital
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ChenzhouChinaUnknown status
The Fourth People's Hospital of Chenzhou
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ChenzhouChinaUnknown status
The Second People's Hospital of Dongying
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DongyingChinaUnknown status
Taihe County Traditional Chinese Medicine Hospital
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FuyangChinaUnknown status
Gaomi People's Hospital
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GaomiChinaUnknown status
Guangdong Second Provincial General Hospital
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GuangzhouChinaUnknown status
The Second People's Hospital of Guiyang
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GuiyangChinaUnknown status
The Second Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Haikou People's Hospital
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HaikouChinaUnknown status
Qiu County People's Hospital
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HandanChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Lixin County People's Hospital
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HaozhouChinaUnknown status
The 2nd Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
The First Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
Hengyang Central Hospital
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HengyangChinaUnknown status
Heyuan People's Hospital
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HeyuanChinaUnknown status
Huazhou People's Hospital
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HuazhouChinaUnknown status
Jiaozuo Coal Industry Central Hospital
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JiaozuoChinaUnknown status
The First Affiliated Hospital of Jinzhou Medical University
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JinzhouChinaUnknown status
Jiujiang First People's Hospital
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JiujiangChinaUnknown status
Keshketeng Banner Chinese-Mongolian Hospital
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Keshketeng BannerChinaUnknown status
Laizhou City People's Hospital,
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LaizhouChinaUnknown status
Linfen Central Hospital
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LinfenChinaUnknown status
The first people hospital of lingbao
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LingbaoChinaUnknown status
Linyi People's Hospital
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LinyiChinaUnknown status
Liuyang Jili Hospital
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LiuyangChinaUnknown status
Nanshi Hospital of Nanyang
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NanyangChinaUnknown status
Ningbo Beilun District People's Hospital
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NingboChinaUnknown status
Nanle Zhongxing Hospital
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PuyangChinaUnknown status
Nanle county people's hospital
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PuyangChinaUnknown status
Puyang Oilfield General Hospital
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PuyangChinaUnknown status
Qiandongnanzhou People's Hospital
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QiandongnanChinaUnknown status
QingDao Municipal Hospital
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QingdaoChinaUnknown status
The Second Hospital of Qinhuangdao
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QinhuangdaoChinaUnknown status
Shaoguan Qujiang District People's Hospital
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ShaoguanChinaUnknown status
The People's Hospital of Liaoning Province
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ShenyangChinaUnknown status
Hongxinglong Hospital of Beidahuang Group
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ShuangyashanChinaUnknown status
Siping City Central People's Hospital
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SipingChinaUnknown status
The Second Affiliated Hospital of Shandong First Medical University
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TaianChinaUnknown status
Tangshan Guye Traditional Chinese Medicine Hospital
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TangshanChinaUnknown status
First People's Hospital of Tianshui
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TianshuiChinaUnknown status
Liuhe County People's Hospital
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TonghuaChinaUnknown status
Tongliao People's Hospital
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TongliaoChinaUnknown status
The Affiliated Hospital of Shandong Second Medical University
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WeifangChinaUnknown status
Weifang People's Hospital
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WeifangChinaUnknown status
Weihai Central Hospital
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WeihaiChinaUnknown status
Qinghe County People's Hospital
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XingtaiChinaUnknown status
Guangshan County People's Hospital
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XinyangChinaUnknown status
Xi County People's Hospital
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XinyangChinaUnknown status
Yantai Taochun Central Hospital
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YantaiChinaUnknown status
Zaozhuang Municipal Hospital
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ZaozhuangChinaUnknown status
Taikang Xian People's Hospital
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ZhoukouChinaUnknown status
Zhumadian Traditional Chinese Medicine Hospital
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ZhumadianChinaUnknown status
People's Hospital of Queshan
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ZhumadianChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.