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Acute Ischemic StrokePhase 3TRACEⅡNCT04797013

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

A Phase 3 study testing rt-PA and rhTNK-tPA in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 61 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
rt-PA and rhTNK-tPA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,430 participants
Where
61 sitesChina
Study dates
12 Jun 2021to 15 Jul 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 24Show fewer
  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

China61 sites

  • Inner Mongolia Baotou Hospita

    Baotou, Inner Mongolia, 014

  • Beijing luhe hospital capital medical university

    Beijing, Beijing Municipality, 100000

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • First Hospital of Jilin University

    Changchun, Jilin, 130

  • Heping hospital affiliated to changzhi medical college

    Changzhi, Shanxi, 046000

  • Affiliated hospital of chengde medical university

    Chengde, Hebei, 067000

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024000

  • Kashkten Mongolian Medicine Hospital

    Chifeng, Inner Mongolia, 024000

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404100

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

  • General Hospital of Chinese Medicine and Coal

    Datong, Shanxi, 037000

  • The fifth people's s hospital of datong

    Datong, Shanxi, 037000

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangdong, Guangdong, 510000

  • Guizhou provincial people's hospital

    Guiyang, Guizhou, 550000

  • The 2ad affiliated hospital of harbin medical university

    Haerbin, Heilongjiang, 150000

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • The first affiliated hospital of ustc

    Hefei, Anhui, 230000

  • Inner Mongolia People'S Hospital

    Hohhot, Inner Mongolia, 010000

  • Huai an second people's hospital

    Huaian, Jiangsu, 223001

  • Second People's Hospital of Jiaozuo City

    Jiaozuo, Henan, 454150

  • The Firet Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • The first hospital of lanzhou university

    Lanzhou, Gansu, 730000

  • Linfen central hospital

    Linfen, Shanxi, 041000

  • Linfen people's hospital

    Linfen, Shanxi, 041000

  • Linyi City People Hospital

    Linyi, Shandong, 276000

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

  • Mianyang central hospital

    Mianyang, Sichuan, 621000

  • Third Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Nanyang central hospital

    Nanyang, Henan, 473000

  • Nanyang Nanshi Hospital

    Nanyang, Henan, 473000

  • Nayang second general hospital

    Nanyang, Henan, 473000

  • Pingmei Shenma Medical Group General Hospital

    Pingdingshan, Henan, 467000

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Yue bei people's hospital

    Shaoguan, Guangdong, 512000

  • Central hospital affiliated to shenyang medical college

    Shenyang, Liaoning, 110000

  • General Hospital of Northern War Zone, PLA

    Shenyang, Liaoning, 110000

  • The first hospital of china medical university

    Shenyang, Liaoning, 110000

  • The First People'S Hospital of Shenyang

    Shenyang, Liaoning, 110000

  • The first hospital of hebei medical university

    Shijiazhuang, Hebei, 050000

  • the Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Jilin neuropsychiaric hospital

    Siping, Jilin, 136000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030000

  • Shanxi provincial prople's hospital

    Taiyuan, Taiyuan, 030000

  • Jiangsu taizhou people's hopital

    Taizhou, Jiangsu, 225300

  • Taizhou Enze Medical Center ( Group )

    Taizhou, Zhejiang, 318000

  • Tangshan Workers ' Hospital

    Tangshan, Hebei, 063000

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong, 277559

  • Tonghua Central Hospital

    Tonghua, Jilin, 134000

  • Meihekou Central Hospital

    Tonghua, Jilin, 135000

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang, 325000

  • The central hospital of wuhan

    Wuhan, Hunan, 430000

  • Xianyang Hospital of Yan ' an University

    Xianyang, Shanxi, 712000

  • Xinxiang first people's hospital

    Xinxiang, Henan, 453000

  • Xinyang central hospital

    Xinyang, Henan, 464000

  • The people's hospltal of xuancheng city

    Xuancheng, Anhui, 242000

  • General Hospital of Xuzhou Mining Group

    Xuzhou, Jiangsu, 221000

  • Xuzhou central hospital

    Xuzhou, Jiangsu, 221000

  • Yantai Yuhuangding Hosopital

    Yantai, Shandong, 264000

  • The first affiliated hospital of hebei north university

    Zhangjiakou, Hebei, 075000

  • The first affiliated hospital of zhengzhou university

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial

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

Read the detailed description

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.

Being tested
rt-PA, rhTNK-tPA
Keywords
rhTNK-tPA, acute, stroke, phaseⅢ, Acute Ischemic Stroke, rt-PA
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.

  • rt-PADrug

    Also called Alteplase injection (rt-PA)

    Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.

  • rhTNK-tPADrug

    Also called Recombinant Human TNK Tissue-type Plasminogen Activator for Injection

    Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.

Study groups in NCT04797013
Study groupRoleWhat they receive
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.
Receives: Drug: rhTNK-tPA
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.
Receives: Drug: rt-PA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excellent functional outcome

    Proportion of subjects with mRS(0-1) at 90 days.

    Measured: 90 days

Secondary outcomes (5)

  1. Good functional outcome

    Proportion of subjects with mRS(0-2) at 90 days.

    Measured: 90 days

  2. National Institutes of Health Stroke Scale (NIHSS)

    Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.

    Measured: 24 hours，day7

  3. EQ-5D

    Quality of life measured by EQ-5D scale.

    Measured: 90 days

  4. Barthel (BI)

    Global function of daily living defined as BI ≥ 95 at 90 days.

    Measured: 90 days

  5. Modified Rankin Scale(mRS)

    Ordinal distribution of mRS at 90 days.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start12 Jun 2021
  3. Primary completion29 May 2022
  4. Study completion15 Jul 2022

Resources

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
Model description
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797013
Sponsor's protocol ID
MK02-2020-01
Acronym
TRACEⅡ
Status last verified
Jan 2023
First submitted
25 Feb 2021
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32078683

  • 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.

    PubMed 31318627

  • 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.

    PubMed 18815396

  • 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.

    PubMed 31128925

  • 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.

    PubMed 25106063

  • 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.

    PubMed 32943483

  • 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.

    PubMed 25726502

  • 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.

    PubMed 28780236

  • 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.

    PubMed 30117036

  • 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.

    PubMed 31662117

  • 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.

    PubMed 29367334

  • 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.

    PubMed 32561535

  • 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.

    PubMed 31067369

  • 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.

    PubMed 29766770

  • 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.

    PubMed 27462117

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rt-PA and rhTNK-tPA in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 61 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 6 inclusion and 24 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: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excellent functional outcome (time frame: 90 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 NCT04797013, which also lists 29 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 17 Jan 2023.

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