Acute Ischemic StrokePhase 3NCT05745259
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）
A Phase 3 study testing Alteplase and Tenecteplase in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 63 sites in China.
Trial summary
The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Alteplase and Tenecteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,630 participants
- Where
- 63 sitesChina
- Study dates
- 26 Oct 2022to 29 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤Age≤80 years old;
- The clinical diagnosis was Acute ischemic stroke 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";
- MRS before onset was ≤1 points;
- Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
- Informed consent from the patient or surrogate.
Who cannot join
- Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)
- Patients planning to receive endovascular therapy
- A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)
- Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.
- Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range.
Show all 23Show fewer
- Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s;
- Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count;
- BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, measured for three times every 10 minutes.
- Platelet count of less than 100×109/ L;
- Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L);
- History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding)
- Tumors with an increased risk of bleeding.
- Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein
- Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis;
- Aortic arch dissection;
- Major surgery or severe trauma in the past 2 weeks;
- Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months;
- Unable to complete neurological assessment and follow-up visits because of dementia or mental illness;
- Pregnant women, lactating women, or have positive pregnancy test;
- Allergy to tenecteplase or alteplase or their components;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
China63 sites, 62 recruiting
- Not yet recruiting
Anyang People's Hospital
Anyang, Henan, 455100
Yun Zhang, 16637232838, 13937210880@163.com
Yun Zhang
- Not yet recruiting
Baogang Hospital of Inner Monglia
Baotou, Inner Monglia, 014010
Suping Wang, 13948522612, 13948522612@163.com
Suping Wang
- Not yet recruiting
Baotou Central Hospital
Baotou, Inner Mongolia, 014010
Baojun Wang, 13384858794, jbwwbj@126.com
Baojun Wang
- Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, 100000
Yongjun Wang, 13911172565, yongjunwang111@aliyun.com
Yongjun U Wang
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Qingfeng Ma, 18510929092, m.qingfeng@163.com
Qingfeng Ma
- Recruiting
Beipiao Central Hospital
Beipiao, Liaoning, 122000
Yutong Ma, 18642143339, myt3339@163.com
Yutong Ma
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Yi Yang, 13756661217, doctoryangyi@163.com
Yi Yang
- Recruiting
Keshenketengqi Mongolian Medicine Hospital
Chifeng, Inner Mongolia, 025300
Guozhi Lu, 13722169555, 1073281716@qq.com
Guozhi Lu
- Terminated
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 404100
- Not yet recruiting
Dalian Central Hospital
Dalian, Liaoning, 116000
Lizhen Zhong, 19969310278, zlz0117@163.com
Lizhen Zhong
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000
Dan Deng, 18245977799, syb030407@qq.com
Dan Deng
- Not yet recruiting
Daqing People's Hospital
Daqing, Heilongjiang, 163000
Dexin Luo, 13359608879, dr.ldx@163.com
Dexin Luo
- Not yet recruiting
Sinopharm Coal Mine General Hospital
Datong, Shanxi, 037000
Junhai Wang, 13753265757, wjh1964@sohu.com
Junhai Wang
- Not yet recruiting
Dazhu County People's Hospital
Dazhu, Sichuan, 635199
Zhaohui Li, 13982833951, 187188178@qq.com
Zhaohui Li
- Not yet recruiting
Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
Dezhou, Shandong, 253000
Lixin Qu, 15589185707, Qulx12060057@163.com
Qu Lixin
- Not yet recruiting
Fushun Mining Bureau General Hospital
Fushun, Liaoning, 113000
Hong Zhang, 15694236301, zhanghong429@163.com
Hong Zhang
- Not yet recruiting
Liaoning Health Industry Group Fuxin Mine General Hospital
Fuxin, Liaoning, 123100
Yingjie Duan, 13470363261, 451142359@qq.com
Yingjie Duan
- Not yet recruiting
Handan Central Hospital
Handan, Hebei, 056000
Zhongbo Zhang, 13831000939, 36471980@qq.com
Zhongbo Zhang
- Recruiting
Hengshui people's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, 053000
Yan Wei, 18003188568, hayuanwy@163.com
Yan Wei
- Not yet recruiting
The Third People's Hospital of Huizhou
Huizhou, Guangdong, 516000
Zhongyuan Piao, 18829975340, piaozhongyuan@126.com
Zhongyuan Piao
- Not yet recruiting
Jiaozuo People's Hospital
Jiaozuo, Henan, 454000
Haidong Lv, 13598509338, hnlhd666@163.com
Haidong Lv
- Not yet recruiting
Jinan People's Hospital
Jinan, Shandong, 250000
Menghai Wu, 18963431366, 24967496@qq.com
Menghai Wu
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Wei Wu, 18560082121, drwuwei@126.com
Wei Wu
- Not yet recruiting
The First People's Hospital of Jingzhou
Jingzhou, Hubei, 434000
Tao Yang, 18163139070, yangtao9819@163.com
Tao Yang
- Not yet recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
Xuewen Liu, 13940644988, sjnklxw@163.com
Xuewen Liu
- Not yet recruiting
Lanzhou University First Hospital
Lanzhou, Gansu, 730000
Jun Chen, 13993193823, cj0158@163.com
Jun Chen
- Not yet recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252006
Cunju Guo, 13346256168, cunjuguo@163.com
Cunju Guo
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041000
Hongguo Dai, 15935767592, daihongguo3199@163.com
Hongguo Dai
- Not yet recruiting
Linfen People's Hospital
Linfen, Shanxi, 041000
Junfang Hao, 13835360973, haojunfan2012@163.com
Junfang Hao
- Not yet recruiting
Linyi Hospital of Traditional Chinese Medicine
Linyi, Shandong, 273300
Ziran Wang, 13954993801, wzr0806@163.com
Ziran Wang
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 273300
Ziran Wang, 13954993801, wzr0806@163.com
Ziran Wang
- Recruiting
The First People's Hospital of Tancheng County
Linyi, Shandong, 2761000
Wei Du, 13969913520, 529541360@qq.com
Wei Du
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Yufeng Tang, 13981184028, dryufeng@126.com
Yufeng Tang
- Not yet recruiting
Nanyang South Stone Hospital
Nanyang, Henan, 473000
Bin Liu, 13525156232, 813577982@qq.com
Bin Liu
- Not yet recruiting
Pingmei Shenma medical group general hospital
Pingdingshan, Henan, 467000
Hongwei Zhang, 13949457905, jsjyan1zhanghongwei@126.com
Hongwei Zhang
- Not yet recruiting
Quanzhou First Hospital
Quanzhou, Fujian, 362000
Zhuquan Hong, 15345951812, 971696252@qq.com
Zhuquan Hong
- Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guangdong, 512000
Junbin Chen, 13500205898, CJBCL0397@163.com
Junbin Chen
- Not yet recruiting
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning, 111000
Runhui Li, 18002477116, lirh710717@163.com
Runhui Li
- Not yet recruiting
Air Force Hospital of Northern War Zone,PLA
Shenyang, Liaoning, 111000
Jing Wang, 13322445060, hbf44132@163.com
Jing Wang
- Not yet recruiting
General Hospital of Northern War Zone,PLA
Shenyang, Liaoning, 111000
Huisheng Chen, 13352452086, chszh@aliyun.com
Huisheng Chen
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 111000
Chuansheng Zhao, 13940369251, chszh@aliyun.com
Chuansheng Zhao
- Not yet recruiting
The First People's Hospital of Shenyang
Shenyang, Liaoning, 111000
Yi Sui, 13998352587, tjyiia@hotmail.com
Yi Sui
- Not yet recruiting
Jilin Guowen Hospital
Siping, Jilin, 136000
Jinming Ding, 13630703939, 274486000@163.com
Jinming Ding
- Not yet recruiting
Siping Central People's Hospital
Siping, Jilin, 136000
Junfeng Zhao, 13843443119, jlspzjf2727@163.com
Junfeng Zhao
- Not yet recruiting
The Second Affiliated Hospital of Suzhou Medical University
Suzhou, Jiangsu, 215000
Chunfeng Liu, 13606210609, liucf20@163.com
Chunfeng Liu
- Not yet recruiting
Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
Taian, Shandong, 271000
Yunlin Liu, 13375388398, bb0538@163.com
Yunlin Liu
- Not yet recruiting
Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi, 030000
Weirong Li, 18735133366, weironglee@163.com
Weirong Li
- Not yet recruiting
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Ying Liu, 13952618801, 13952618801@163.com
Ying Liu
- Not yet recruiting
Tangshan Workers' Hospital
Tangshan, Hebei, 063000
Jing Liu, 15903159765, angel.jsea@163.com
Jing Liu
- Not yet recruiting
Tengzhou Central Hospital
Tengzhou, Shandong, 277500
Deyang Li, 13561190369, lideyang0632@163.com
Deyang Li
- Not yet recruiting
Tonghua Central Hospital
Tonghua, Jilin, 134100
Lianhuan Zhang, 15944509098, 15944509098@163.com
Lianhuan Zhang
- Not yet recruiting
Meihekou Central Hospital
Tonghua, Jilin, 135000
Hong Yu, 13844564195, 2823974848@qq.com
Shugen Han
- Not yet recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261000
Tao Liu, 13791699198, liutao.wf@163.com
Tao Liu
- Not yet recruiting
Xinxiang Central Hospital
Xinxiang, Henan, 453000
Min Zhang, 15637359131, hyszhangmin@sina.com
Min Zhang
- Not yet recruiting
Xuancheng People's Hospital
Xuancheng, Anhui, 242000
Yinong Chen, 15956360890, 2chenyinon@163.com
Yinong Chen
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Guofang Chen, 18952172823, cgfxdd@126.com
Guofang Chen
- Not yet recruiting
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu, 221000
Xiu 'e Wei, 15005206672, wxeqq@163.com
Xiu 'e Wei
- Not yet recruiting
The Affiliated Hospital of Xuhzou Meidcal University
Xuzhou, Jiangsu, 221006
Yanbo Cheng, 18052268195, 46140705@qq.com
Yanbo Cheng
- Not yet recruiting
Yantai Yuhangding Hospital
Yantai, Shandong, 264000
Zhigang Liang, 13723987720, zgliang@hotmail.com
Zhigang Liang
- Not yet recruiting
General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
Yinchuan, Ningxia, 750000
Xuewen Fan, 13709575965, nxfxw@163.com
Xuewen Fan
- Not yet recruiting
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750000
Xiangdong Bai, 13909595823, xdwhite@163.com
Xiangdong Bai
- Not yet recruiting
The First People's Hospital of Yulin
Yulin, Guangxi, 541000
Weilin Liang, 13607758784, Lwl2674238@163.com
Weilin Liang
- Not yet recruiting
Zhoukou Downtown Hospital
Zhoukou, Henan, 466000
Lei Xia, 18639493636, 391114308@qq.com
Lei Xia
About this study
Official title: Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ
The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.
Read the detailed description
The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Alteplase, Tenecteplase
- Keywords
- TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called rt-PA
Alteplase 0.9mg/kg are being used.
TenecteplaseDrug
Also called TNK-tPA
Tenecteplase 0.25mg/kg are being used.
| Study group | Role | What they receive |
|---|---|---|
| Alteplase | Active comparator | Patients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour. Receives: Drug: Alteplase |
| Tenecteplase | Experimental | Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds Receives: Drug: Tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
Measured: 90±7 days
Secondary outcomes (6)
National Institutes of Health Stroke Scale (NIHSS)
NIHSS score at 24±2 hours.
Measured: 24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first)
Measured: 7±2days or discharge
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-2) at 90±7 days.
Measured: 90±7 days
Modified Rankin Scale(mRS)
mRS scores at 90±7 days.
Measured: 90±7 days
The new vascular events
Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)
Measured: 90±7 days
EQ-5D
EQ-5D scores at 90±7 days.
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start26 Oct 2022
- Primary completion4 Nov 2023 (estimated)
- Study completion29 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd, The Place Pharmaceutical(Jiangsu) Co., Ltd
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Shuya Li, Study director, IRB of Beijing Tiantan Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745259
- Sponsor's protocol ID
- PR-FHSW-2022001F
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guidelines Editing Group of Chinese Stroke Society, Guidelines for the Diagnosis and Treatment of High-risk Non-Disabling Ischemic Cerebrovascular Events, Chinese Journal of Stroke, June 2016, 11 (6), p481-491.
Chinese Journal of Circulation, China Cardiovascular Disease Report 2015.
CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.
PubMed 9186381Hao Zilong, Liu Ming, Li Wei, et al. Stroke registration method and basic characteristics and functional outcomes of 3123 patients in Chengdu [J]. Chinese Journal of Neurology, 2011,12 (44) : 826-831.
Wang Z, Li J, Wang C, Yao X, Zhao X, Wang Y, Li H, Liu G, Wang A, Wang Y. Gender differences in 1-year clinical characteristics and outcomes after stroke: results from the China National Stroke Registry. PLoS One. 2013;8(2):e56459. doi: 10.1371/journal.pone.0056459. Epub 2013 Feb 13.
PubMed 23418571Wei JW, Heeley EL, Wang JG, Huang Y, Wong LK, Li Z, Heritier S, Arima H, Anderson CS; ChinaQUEST Investigators. Comparison of recovery patterns and prognostic indicators for ischemic and hemorrhagic stroke in China: the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment) Registry study. Stroke. 2010 Sep;41(9):1877-83. doi: 10.1161/STROKEAHA.110.586909. Epub 2010 Jul 22.
PubMed 20651267Bandera E, Botteri M, Minelli C, Sutton A, Abrams KR, Latronico N. Cerebral blood flow threshold of ischemic penumbra and infarct core in acute ischemic stroke: a systematic review. Stroke. 2006 May;37(5):1334-9. doi: 10.1161/01.STR.0000217418.29609.22. Epub 2006 Mar 30.
PubMed 16574919Donnan GA, Baron JC, Ma H, Davis SM. Penumbral selection of patients for trials of acute stroke therapy. Lancet Neurol. 2009 Mar;8(3):261-9. doi: 10.1016/S1474-4422(09)70041-9.
PubMed 19233036Haley EC Jr, Thompson JL, Grotta JC, Lyden PD, Hemmen TG, Brown DL, Fanale C, Libman R, Kwiatkowski TG, Llinas RH, Levine SR, Johnston KC, Buchsbaum R, Levy G, Levin B; Tenecteplase in Stroke Investigators. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr;41(4):707-11. doi: 10.1161/STROKEAHA.109.572040. Epub 2010 Feb 25.
PubMed 20185783Parsons 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.
PubMed 22435369Huang 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.
PubMed 25726502Logallo 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.
PubMed 28780236Campbell 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.
PubMed 29694815Emberson 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.
PubMed 25106063National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
PubMed 7477192
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ
- ClinicalTrials.gov ID
- NCT05745259
- Acronym / sponsor ID
- PR-FHSW-2022001F
- Conditions
- Acute Ischemic Stroke
- Keywords
- TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,630 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd, The Place Pharmaceutical(Jiangsu) Co., Ltd
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 4 Nov 2023 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.
Detailed description
The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase | Active comparator | Drug: AlteplasePatients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour. |
| Tenecteplase | Experimental | Drug: TenecteplasePatients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18≤Age≤80 years old;
- The clinical diagnosis was Acute ischemic stroke 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";
- MRS before onset was ≤1 points;
- Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
- Informed consent from the patient or surrogate.
Key exclusion criteria (23 listed)
- Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)
- Patients planning to receive endovascular therapy
- A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)
- Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAlso: rt-PAAlteplase 0.9mg/kg are being used. | Drug | Alteplase |
| TenecteplaseAlso: TNK-tPATenecteplase 0.25mg/kg are being used. | Drug | Tenecteplase |
Primary outcome
Modified Rankin Scale(mRS)
Time frame: 90±7 days
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
6 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 7±2days or discharge
Modified Rankin Scale(mRS)
Time frame: 90±7 days
Modified Rankin Scale(mRS)
Time frame: 90±7 days
The new vascular events
Time frame: 90±7 days
EQ-5D
Time frame: 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- BackgroundGuidelines Editing Group of Chinese Stroke Society, Guidelines for the Diagnosis and Treatment of High-risk Non-Disabling Ischemic Cerebrovascular Events, Chinese Journal of Stroke, June 2016, 11 (6), p481-491.
- BackgroundChinese Journal of Circulation, China Cardiovascular Disease Report 2015.
- Background: PubMed 9186381CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.
- BackgroundHao Zilong, Liu Ming, Li Wei, et al. Stroke registration method and basic characteristics and functional outcomes of 3123 patients in Chengdu [J]. Chinese Journal of Neurology, 2011,12 (44) : 826-831.
- Background: PubMed 23418571Wang Z, Li J, Wang C, Yao X, Zhao X, Wang Y, Li H, Liu G, Wang A, Wang Y. Gender differences in 1-year clinical characteristics and outcomes after stroke: results from the China National Stroke Registry. PLoS One. 2013;8(2):e56459. doi: 10.1371/journal.pone.0056459. Epub 2013 Feb 13.
- Background: PubMed 20651267Wei JW, Heeley EL, Wang JG, Huang Y, Wong LK, Li Z, Heritier S, Arima H, Anderson CS; ChinaQUEST Investigators. Comparison of recovery patterns and prognostic indicators for ischemic and hemorrhagic stroke in China: the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment) Registry study. Stroke. 2010 Sep;41(9):1877-83. doi: 10.1161/STROKEAHA.110.586909. Epub 2010 Jul 22.
- Background: PubMed 16574919Bandera E, Botteri M, Minelli C, Sutton A, Abrams KR, Latronico N. Cerebral blood flow threshold of ischemic penumbra and infarct core in acute ischemic stroke: a systematic review. Stroke. 2006 May;37(5):1334-9. doi: 10.1161/01.STR.0000217418.29609.22. Epub 2006 Mar 30.
- Background: PubMed 19233036Donnan GA, Baron JC, Ma H, Davis SM. Penumbral selection of patients for trials of acute stroke therapy. Lancet Neurol. 2009 Mar;8(3):261-9. doi: 10.1016/S1474-4422(09)70041-9.
- Background: PubMed 20185783Haley EC Jr, Thompson JL, Grotta JC, Lyden PD, Hemmen TG, Brown DL, Fanale C, Libman R, Kwiatkowski TG, Llinas RH, Levine SR, Johnston KC, Buchsbaum R, Levy G, Levin B; Tenecteplase in Stroke Investigators. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr;41(4):707-11. doi: 10.1161/STROKEAHA.109.572040. Epub 2010 Feb 25.
- Background: PubMed 22435369Parsons 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.
- Background: PubMed 25726502Huang 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.
- Background: PubMed 28780236Logallo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuya Li study director
IRB of Beijing Tiantan Hospital,Capital Medical University
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alteplase and Tenecteplase in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 63 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (13911172565, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale(mRS) (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745259, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.