Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
NCT ID: NCT04797013
Last Updated: 2023-01-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1430 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-12
Study Completion Date
2022-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)
NCT04676659
Acute Ischemic Stroke
COMPLETED
PHASE2
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）
NCT05745259
Acute Ischemic Stroke
UNKNOWN
PHASE3
Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
NCT07201688
Acute Ischemic Stroke
RECRUITING
PHASE3
Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window
NCT05752916
Acute Ischemic Stroke
COMPLETED
PHASE4
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
NCT05281549
Acute Ischemic Stroke
UNKNOWN
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Acute Ischemic Stroke
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rhTNK-tPA (0.25mg/kg)
rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
Group Type
ACTIVE_COMPARATOR
rhTNK-tPA
Intervention Type
DRUG
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
rt-PA (0.9mg/kg)
10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
Group Type
ACTIVE_COMPARATOR
rt-PA
Intervention Type
DRUG
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rt-PA
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Intervention Type
DRUG
rhTNK-tPA
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Alteplase injection (rt-PA)
Recombinant Human TNK Tissue-type Plasminogen Activator for Injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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;
* 2 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;
* Blood glucose \<2.8 mmol/L or \>22.22 mmol/L;
* Oral warfarin anticoagulant with INR\>1.7 or PT\>15 s;
* Heparin treatment was received within 24 h;
* Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
* Head CT or MRI showed a large infarction (infarcted area \> 1/3 of the middle cerebral artery);
* Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
* Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
* Participation in other clinical trials within 3 months prior to screening;
* Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
* 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;
* 2 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;
* Blood glucose \<2.8 mmol/L or \>22.22 mmol/L;
* Oral warfarin anticoagulant with INR\>1.7 or PT\>15 s;
* Heparin treatment was received within 24 h;
* Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
* Head CT or MRI showed a large infarction (infarcted area \> 1/3 of the middle cerebral artery);
* Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
* Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
* Participation in other clinical trials within 3 months prior to screening;
* Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Beijing Tiantan Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yongjun Wang
President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wei Sun
Role: STUDY_DIRECTOR
IRB of Beijing Tiantan Hospital,Capital Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The first affiliated hospital of ustc
Hefei, Anhui, China
Site Status
The people's hospltal of xuancheng city
Xuancheng, Anhui, China
Site Status
Beijing luhe hospital capital medical university
Beijing, Beijing Municipality, China
Site Status
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Site Status
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Site Status
The first hospital of lanzhou university
Lanzhou, Gansu, China
Site Status
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong, Guangdong, China
Site Status
Yue bei people's hospital
Shaoguan, Guangdong, China
Site Status
Guizhou provincial people's hospital
Guiyang, Guizhou, China
Site Status
Affiliated hospital of chengde medical university
Chengde, Hebei, China
Site Status
The first hospital of hebei medical university
Shijiazhuang, Hebei, China
Site Status
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Site Status
Tangshan Workers ' Hospital
Tangshan, Hebei, China
Site Status
The first affiliated hospital of hebei north university
Zhangjiakou, Hebei, China
Site Status
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Site Status
The 2ad affiliated hospital of harbin medical university
Haerbin, Heilongjiang, China
Site Status
Second People's Hospital of Jiaozuo City
Jiaozuo, Henan, China
Site Status
Nanyang central hospital
Nanyang, Henan, China
Site Status
Nanyang Nanshi Hospital
Nanyang, Henan, China
Site Status
Nayang second general hospital
Nanyang, Henan, China
Site Status
Pingmei Shenma Medical Group General Hospital
Pingdingshan, Henan, China
Site Status
Xinxiang first people's hospital
Xinxiang, Henan, China
Site Status
Xinyang central hospital
Xinyang, Henan, China
Site Status
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
Site Status
The central hospital of wuhan
Wuhan, Hunan, China
Site Status
Inner Mongolia Baotou Hospita
Baotou, Inner Mongolia, China
Site Status
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, China
Site Status
Kashkten Mongolian Medicine Hospital
Chifeng, Inner Mongolia, China
Site Status
Inner Mongolia People'S Hospital
Hohhot, Inner Mongolia, China
Site Status
Huai an second people's hospital
Huaian, Jiangsu, China
Site Status
Jiangsu taizhou people's hopital
Taizhou, Jiangsu, China
Site Status
General Hospital of Xuzhou Mining Group
Xuzhou, Jiangsu, China
Site Status
Xuzhou central hospital
Xuzhou, Jiangsu, China
Site Status
Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Site Status
First Hospital of Jilin University
Changchun, Jilin, China
Site Status
Jilin neuropsychiaric hospital
Siping, Jilin, China
Site Status
Tonghua Central Hospital
Tonghua, Jilin, China
Site Status
Meihekou Central Hospital
Tonghua, Jilin, China
Site Status
The Firet Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Site Status
Central hospital affiliated to shenyang medical college
Shenyang, Liaoning, China
Site Status
General Hospital of Northern War Zone, PLA
Shenyang, Liaoning, China
Site Status
The first hospital of china medical university
Shenyang, Liaoning, China
Site Status
The First People'S Hospital of Shenyang
Shenyang, Liaoning, China
Site Status
Linyi City People Hospital
Linyi, Shandong, China
Site Status
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Site Status
Yantai Yuhuangding Hosopital
Yantai, Shandong, China
Site Status
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Site Status
Heping hospital affiliated to changzhi medical college
Changzhi, Shanxi, China
Site Status
General Hospital of Chinese Medicine and Coal
Datong, Shanxi, China
Site Status
The fifth people's s hospital of datong
Datong, Shanxi, China
Site Status
Linfen central hospital
Linfen, Shanxi, China
Site Status
Linfen people's hospital
Linfen, Shanxi, China
Site Status
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Site Status
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Site Status
Xianyang Hospital of Yan ' an University
Xianyang, Shanxi, China
Site Status
Mianyang central hospital
Mianyang, Sichuan, China
Site Status
Shanxi provincial prople's hospital
Taiyuan, Taiyuan, China
Site Status
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
Lishui Central Hospital
Lishui, Zhejiang, China
Site Status
Taizhou Enze Medical Center ( Group )
Taizhou, Zhejiang, China
Site Status
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
References
Explore related publications, articles, or registry entries linked to this study.
Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Zhao H, Alemseged F, Ng F, Bailey P, Rice H, de Villiers L, Dewey HM, Choi PMC, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Kraemer T, Krause M, Cordato D, Field D, Ma H, O'Brien B, Clissold B, Miteff F, Clissold A, Cloud GC, Bolitho LE, Bonavia L, Bhattacharya A, Wright A, Mamun A, O'Rourke F, Worthington J, Wong AA, Levi CR, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Part 2 investigators. Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1257-1265. doi: 10.1001/jama.2020.1511.
Reference Type
BACKGROUND
Burgos AM, Saver JL. Evidence that Tenecteplase Is Noninferior to Alteplase for Acute Ischemic Stroke: Meta-Analysis of 5 Randomized Trials. Stroke. 2019 Aug;50(8):2156-2162. doi: 10.1161/STROKEAHA.119.025080. Epub 2019 Jul 18.
Reference Type
BACKGROUND
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
Reference Type
BACKGROUND
Campbell BCV, Ma H, Ringleb PA, Parsons MW, Churilov L, Bendszus M, Levi CR, Hsu C, Kleinig TJ, Fatar M, Leys D, Molina C, Wijeratne T, Curtze S, Dewey HM, Barber PA, Butcher KS, De Silva DA, Bladin CF, Yassi N, Pfaff JAR, Sharma G, Bivard A, Desmond PM, Schwab S, Schellinger PD, Yan B, Mitchell PJ, Serena J, Toni D, Thijs V, Hacke W, Davis SM, Donnan GA; EXTEND, ECASS-4, and EPITHET Investigators. Extending thrombolysis to 4.5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data. Lancet. 2019 Jul 13;394(10193):139-147. doi: 10.1016/S0140-6736(19)31053-0. Epub 2019 May 22.
Reference Type
BACKGROUND
Emberson J, Lees KR, Lyden P, Blackwell L, Albers G, Bluhmki E, Brott T, Cohen G, Davis S, Donnan G, Grotta J, Howard G, Kaste M, Koga M, von Kummer R, Lansberg M, Lindley RI, Murray G, Olivot JM, Parsons M, Tilley B, Toni D, Toyoda K, Wahlgren N, Wardlaw J, Whiteley W, del Zoppo GJ, Baigent C, Sandercock P, Hacke W; Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014 Nov 29;384(9958):1929-35. doi: 10.1016/S0140-6736(14)60584-5. Epub 2014 Aug 5.
Reference Type
BACKGROUND
Kunz WG, Hunink MG, Almekhlafi MA, Menon BK, Saver JL, Dippel DWJ, Majoie CBLM, Jovin TG, Davalos A, Bracard S, Guillemin F, Campbell BCV, Mitchell PJ, White P, Muir KW, Brown S, Demchuk AM, Hill MD, Goyal M; HERMES Collaborators. Public health and cost consequences of time delays to thrombectomy for acute ischemic stroke. Neurology. 2020 Nov 3;95(18):e2465-e2475. doi: 10.1212/WNL.0000000000010867. Epub 2020 Sep 17.
Reference Type
BACKGROUND
Huang X, Cheripelli BK, Lloyd SM, Kalladka D, Moreton FC, Siddiqui A, Ford I, Muir KW. Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study. Lancet Neurol. 2015 Apr;14(4):368-76. doi: 10.1016/S1474-4422(15)70017-7. Epub 2015 Feb 26.
Reference Type
BACKGROUND
Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.
Reference Type
BACKGROUND
Kheiri B, Osman M, Abdalla A, Haykal T, Ahmed S, Hassan M, Bachuwa G, Al Qasmi M, Bhatt DL. Tenecteplase versus alteplase for management of acute ischemic stroke: a pairwise and network meta-analysis of randomized clinical trials. J Thromb Thrombolysis. 2018 Nov;46(4):440-450. doi: 10.1007/s11239-018-1721-3.
Reference Type
BACKGROUND
Warner JJ, Harrington RA, Sacco RL, Elkind MSV. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke. Stroke. 2019 Dec;50(12):3331-3332. doi: 10.1161/STROKEAHA.119.027708. Epub 2019 Oct 30. No abstract available.
Reference Type
RESULT
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
Reference Type
RESULT
Liu L, Chen W, Zhou H, Duan W, Li S, Huo X, Xu W, Huang L, Zheng H, Liu J, Liu H, Wei Y, Xu J, Wang Y; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of ischaemic cerebrovascular diseases. Stroke Vasc Neurol. 2020 Jun;5(2):159-176. doi: 10.1136/svn-2020-000378. Epub 2020 Jun 18.
Reference Type
RESULT
Ma 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.
Reference Type
RESULT
Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.
Reference Type
RESULT
Seners 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.
Reference Type
RESULT
Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.
Reference Type
RESULT
Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.
Reference Type
RESULT
Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.
Reference Type
RESULT
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.
Reference Type
RESULT
Campbell 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.
Reference Type
RESULT
Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
Reference Type
RESULT
Fassbender 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.
Reference Type
RESULT
Bivard 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.
Reference Type
RESULT
Parsons 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.
Reference Type
RESULT
Coutts 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.
Reference Type
RESULT
Campbell 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.
Reference Type
RESULT
Liu 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.
Reference Type
DERIVED
Wang 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.
Reference Type
DERIVED
Li 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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK02-2020-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion
NCT07302854
NOT_YET_RECRUITING
PHASE2/PHASE3
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III
NCT05141305
COMPLETED
PHASE3
Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
NCT06196320
COMPLETED
PHASE3
Intra-arterial Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Large Vascular Occlusion After Successful Mechanical Thrombectomy Recanalization
NCT05624190
RECRUITING
PHASE4
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
NCT06987305
RECRUITING
PHASE3
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
NCT06078995
UNKNOWN
Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset
NCT07094763
NOT_YET_RECRUITING
NA
Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）
NCT05724342
UNKNOWN
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
NCT06414499
RECRUITING
PHASE3
Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke
NCT04733742
COMPLETED
PHASE2/PHASE3
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
NCT04915729
COMPLETED
PHASE3
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)
NCT05657470
COMPLETED
PHASE2/PHASE3
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
NCT07047014
RECRUITING
PHASE3
A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
NCT04028518
UNKNOWN
PHASE2
A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
NCT02398656
COMPLETED
PHASE3
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
NCT06658197
NOT_YET_RECRUITING
PHASE3
Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
NCT06781385
ENROLLING_BY_INVITATION
PHASE2
Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
NCT07253181
NOT_YET_RECRUITING
PHASE3
MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK
NCT04752631
COMPLETED
PHASE4
Penumbral Based Novel Thrombolytic Therapy in Acute Ischemic Stroke
NCT02101606
COMPLETED
PHASE2
rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage
NCT06814964
RECRUITING
PHASE1
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis
NCT02814409
COMPLETED
PHASE3
Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
NCT04071613
COMPLETED
PHASE2
Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
NCT06696131
NOT_YET_RECRUITING
PHASE1
Tenecteplase Compared to Alteplase for Patients With Large Vesel Oclusion Suspicion Before Thrombectomy
NCT05626972
UNKNOWN
PHASE3