Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
TRACEⅡ
A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial
1 other identifier
interventional
1,430
1 country
61
Brief Summary
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2021
Shorter than P25 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
June 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedJanuary 17, 2023
January 1, 2023
12 months
February 25, 2021
January 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Excellent functional outcome
Proportion of subjects with mRS(0-1) at 90 days.
90 days
Secondary Outcomes (5)
Good functional outcome
90 days
National Institutes of Health Stroke Scale (NIHSS)
24 hours，day7
EQ-5D
90 days
Barthel (BI)
90 days
Modified Rankin Scale(mRS)
90 days
Other Outcomes (7)
Symptomatic intracranial hemorrhage(sICH)
36 hours
Asymptomatic intracranial hemorrhage
90 days
PH2 intracranial hemorrhage
90 days
- +4 more other outcomes
Study Arms (2)
rhTNK-tPA (0.25mg/kg)
ACTIVE COMPARATORrhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
rt-PA (0.9mg/kg)
ACTIVE COMPARATOR10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
Interventions
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Eligibility Criteria
You may qualify if:
- Age ≥18 years old, no gender limitation;
- The time from onset to treatment was \< 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
- The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- MRS before onset was 0-1 points
- Baseline NIHSS 5-25(both included);
- Informed consent from the patient or surrogate.
You may not qualify if:
- Intended to proceed endovascular treatment;
- NIHSS consciousness score \>2;
- Allergy to tenecteplase or alteplase;
- Past history of intracranial hemorrhage ;
- A history of severe head trauma or stroke within 3 months;
- A history of intracranial or spinal surgery within 3 months;
- A history of gastrointestinal or urinary bleeding within 3 weeks;
- weeks of major surgery;
- Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
- Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- Active visceral bleeding;
- Aortic arch dissection was found;
- After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
- Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
The first affiliated hospital of ustc
Hefei, Anhui, 230000, China
The people's hospltal of xuancheng city
Xuancheng, Anhui, 242000, China
Beijing luhe hospital capital medical university
Beijing, Beijing Municipality, 100000, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404100, China
The first hospital of lanzhou university
Lanzhou, Gansu, 730000, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong, Guangdong, 510000, China
Yue bei people's hospital
Shaoguan, Guangdong, 512000, China
Guizhou provincial people's hospital
Guiyang, Guizhou, 550000, China
Affiliated hospital of chengde medical university
Chengde, Hebei, 067000, China
The first hospital of hebei medical university
Shijiazhuang, Hebei, 050000, China
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Tangshan Workers ' Hospital
Tangshan, Hebei, 063000, China
The first affiliated hospital of hebei north university
Zhangjiakou, Hebei, 075000, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000, China
The 2ad affiliated hospital of harbin medical university
Haerbin, Heilongjiang, 150000, China
Second People's Hospital of Jiaozuo City
Jiaozuo, Henan, 454150, China
Nanyang central hospital
Nanyang, Henan, 473000, China
Nanyang Nanshi Hospital
Nanyang, Henan, 473000, China
Nayang second general hospital
Nanyang, Henan, 473000, China
Pingmei Shenma Medical Group General Hospital
Pingdingshan, Henan, 467000, China
Xinxiang first people's hospital
Xinxiang, Henan, 453000, China
Xinyang central hospital
Xinyang, Henan, 464000, China
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, 450000, China
The central hospital of wuhan
Wuhan, Hunan, 430000, China
Inner Mongolia Baotou Hospita
Baotou, Inner Mongolia, 014, China
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, 024000, China
Kashkten Mongolian Medicine Hospital
Chifeng, Inner Mongolia, 024000, China
Inner Mongolia People'S Hospital
Hohhot, Inner Mongolia, 010000, China
Huai an second people's hospital
Huaian, Jiangsu, 223001, China
Jiangsu taizhou people's hopital
Taizhou, Jiangsu, 225300, China
General Hospital of Xuzhou Mining Group
Xuzhou, Jiangsu, 221000, China
Xuzhou central hospital
Xuzhou, Jiangsu, 221000, China
Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
First Hospital of Jilin University
Changchun, Jilin, 130, China
Jilin neuropsychiaric hospital
Siping, Jilin, 136000, China
Tonghua Central Hospital
Tonghua, Jilin, 134000, China
Meihekou Central Hospital
Tonghua, Jilin, 135000, China
The Firet Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000, China
Central hospital affiliated to shenyang medical college
Shenyang, Liaoning, 110000, China
General Hospital of Northern War Zone, PLA
Shenyang, Liaoning, 110000, China
The first hospital of china medical university
Shenyang, Liaoning, 110000, China
The First People'S Hospital of Shenyang
Shenyang, Liaoning, 110000, China
Linyi City People Hospital
Linyi, Shandong, 276000, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, 277559, China
Yantai Yuhuangding Hosopital
Yantai, Shandong, 264000, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000, China
Heping hospital affiliated to changzhi medical college
Changzhi, Shanxi, 046000, China
General Hospital of Chinese Medicine and Coal
Datong, Shanxi, 037000, China
The fifth people's s hospital of datong
Datong, Shanxi, 037000, China
Linfen central hospital
Linfen, Shanxi, 041000, China
Linfen people's hospital
Linfen, Shanxi, 041000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030000, China
Xianyang Hospital of Yan ' an University
Xianyang, Shanxi, 712000, China
Mianyang central hospital
Mianyang, Sichuan, 621000, China
Shanxi provincial prople's hospital
Taiyuan, Taiyuan, 030000, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Lishui Central Hospital
Lishui, Zhejiang, 323000, China
Taizhou Enze Medical Center ( Group )
Taizhou, Zhejiang, 318000, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000, China
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PMID: 32561535RESULTMa H, Campbell BCV, Parsons MW, Churilov L, Levi CR, Hsu C, Kleinig TJ, Wijeratne T, Curtze S, Dewey HM, Miteff F, Tsai CH, Lee JT, Phan TG, Mahant N, Sun MC, Krause M, Sturm J, Grimley R, Chen CH, Hu CJ, Wong AA, Field D, Sun Y, Barber PA, Sabet A, Jannes J, Jeng JS, Clissold B, Markus R, Lin CH, Lien LM, Bladin CF, Christensen S, Yassi N, Sharma G, Bivard A, Desmond PM, Yan B, Mitchell PJ, Thijs V, Carey L, Meretoja A, Davis SM, Donnan GA; EXTEND Investigators. Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke. N Engl J Med. 2019 May 9;380(19):1795-1803. doi: 10.1056/NEJMoa1813046.
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PMID: 29766770RESULTSeners P, Turc G, Maier B, Mas JL, Oppenheim C, Baron JC. Incidence and Predictors of Early Recanalization After Intravenous Thrombolysis: A Systematic Review and Meta-Analysis. Stroke. 2016 Sep;47(9):2409-12. doi: 10.1161/STROKEAHA.116.014181. Epub 2016 Jul 26.
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PMID: 25517348RESULTCampbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.
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PMID: 26898852RESULTFassbender K, Walter S, Grunwald IQ, Merzou F, Mathur S, Lesmeister M, Liu Y, Bertsch T, Grotta JC. Prehospital stroke management in the thrombectomy era. Lancet Neurol. 2020 Jul;19(7):601-610. doi: 10.1016/S1474-4422(20)30102-2.
PMID: 32562685RESULTBivard A, Lin L, Parsonsb MW. Review of stroke thrombolytics. J Stroke. 2013 May;15(2):90-8. doi: 10.5853/jos.2013.15.2.90. Epub 2013 May 31.
PMID: 24324944RESULTParsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.
PMID: 22435369RESULTCoutts SB, Dubuc V, Mandzia J, Kenney C, Demchuk AM, Smith EE, Subramaniam S, Goyal M, Patil S, Menon BK, Barber PA, Dowlatshahi D, Field T, Asdaghi N, Camden MC, Hill MD; TEMPO-1 Investigators. Tenecteplase-tissue-type plasminogen activator evaluation for minor ischemic stroke with proven occlusion. Stroke. 2015 Mar;46(3):769-74. doi: 10.1161/STROKEAHA.114.008504. Epub 2015 Feb 12.
PMID: 25677596RESULTCampbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Dewey HM, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Ang T, Miteff F, Levi CR, Rodrigues E, Zhao H, Salvaris P, Garcia-Esperon C, Bailey P, Rice H, de Villiers L, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Wong AA, Muller C, Coulthard A, Mitchell K, Clouston J, Mahady K, Field D, Ma H, Phan TG, Chong W, Chandra RV, Slater LA, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Investigators. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018 Apr 26;378(17):1573-1582. doi: 10.1056/NEJMoa1716405.
PMID: 29694815RESULTLiu H, Jin A, Pan Y, Meng X, Li H, Li Z, Wang Y, Li S. Efficacy and Safety of Intravenous Tenecteplase Versus Alteplase in Treating Acute Ischemic Stroke With Diabetes and Admission Hyperglycemia. J Am Heart Assoc. 2024 Oct 15;13(20):e036393. doi: 10.1161/JAHA.124.036393. Epub 2024 Oct 11.
PMID: 39392168DERIVEDWang Y, Li S, Pan Y, Li H, Parsons MW, Campbell BCV, Schwamm LH, Fisher M, Che F, Dai H, Li D, Li R, Wang J, Wang Y, Zhao X, Li Z, Zheng H, Xiong Y, Meng X; TRACE-2 Investigators. Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial. Lancet. 2023 Feb 25;401(10377):645-654. doi: 10.1016/S0140-6736(22)02600-9. Epub 2023 Feb 9.
PMID: 36774935DERIVEDLi S, Campbell BCV, Schwamm LH, Fisher M, Parsons M, Li H, Pan Y, Wang Y; TRACE II investigators. Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-II (TRACE II): rationale and design. Stroke Vasc Neurol. 2022 Feb;7(1):71-76. doi: 10.1136/svn-2021-001074. Epub 2021 Aug 26.
PMID: 34446531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei Sun
IRB of Beijing Tiantan Hospital,Capital Medical University
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
- President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 15, 2021
Study Start
June 12, 2021
Primary Completion
May 29, 2022
Study Completion
July 15, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share