Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
TRACE-5
1 other identifier
interventional
452
1 country
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2024
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 9, 2024
CompletedStudy Start
First participant enrolled
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2025
CompletedNovember 26, 2025
April 1, 2025
1.6 years
December 6, 2023
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Modified Rankin Scale (mRS) 0-2 or return to baseline mRS
3 months
Modified Rankin Scale (mRS) 0-3 or return to baseline mRS
3 months
Ordinal analysis of the Modified Rankin Scale (mRS)
3 months
Early neurological improvement
72 hours
Successful reperfusion
initial DSA run prior to thrombectomy
- +5 more secondary outcomes
Study Arms (2)
Tenecteplase
EXPERIMENTALIntravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion
Best Practice (which may include intravenous Alteplase)
ACTIVE COMPARATORIntravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Interventions
Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Taihe County Traditional Chinese Medicine Hospital
Fuyang, Anhui, China
Lixin County People's Hospital
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
Related Publications (1)
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.
PMID: 41151803DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongjun Wang, MD
Beijing Tiantan Hospital
- PRINCIPAL INVESTIGATOR
Bruce Campbell, MD, PhD
University of Melbourne
- STUDY DIRECTOR
Fana Alemseged, MD, PhD
University of Melbourne
- STUDY DIRECTOR
Yunyun Xiong, MD, PhD
Beijing Tiantan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 6, 2023
First Posted
January 9, 2024
Study Start
January 24, 2024
Primary Completion
September 11, 2025
Study Completion
September 22, 2025
Last Updated
November 26, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share