AzTrials
AzTrials

Acute Ischemic StrokePhase 3TRACE- BRIDGENCT07748039

Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

A Phase 3 study testing rhTNK-tPA (0.25mg/kg), Reteplase 10 Units (U) plus a second dose of reteplase 10 U and No thrombolysis (thrombectomy alone) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Yongjun Wang at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rhTNK-tPA (0.25mg/kg), Reteplase 10 Units (U) plus a second dose of reteplase 10 U and No thrombolysis (thrombectomy alone)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,440 participants
Where
5 sitesChina
Study dates
16 Oct 2026to 1 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening.
  • Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1
  • Age ⩾ 18 years at the time of signing the informed consent form
  • ASPECTS 6-10
  • Informed consent from the patients or their legal representative.

Who cannot join

  • Intracranial hemorrhage (ICH) identified by CT or MRI
  • Rapidly improving symptoms at the discretion of the investigator
  • mRS > 2 before stroke onset.
  • Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT.
  • Known contraindication to imaging with contrast agents
  • Planned adjunct intra-arterial (IA) thrombolysis during or after endovascular treatment (EVT).
Show all 10Show fewer
  • Secondary transfer from a primary stroke center
  • Any terminal illness such that patient would not be expected to survive more than one year
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
  • Pregnant women

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongjun Wang, MD contact

+86 13911172565

yongjunwang@ncrcnd.org.cn

Bowei Zhang, MD contact

+86 13001139469

boweizhang@ncrcnd.org.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Beijing Tiantan Hospital, Capital Medical Universiity

    Beijing, Beijing Municipality, 100070

    Bowei Zhang, +86 13001139469, boweizhang@ncrcnd.org.cn

    Recruiting

  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao, Shandong, 625000

    Lei Mou, +86 13686333377, mlwws0633@163.com

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Bin Mei, +86 13037196699, neuromei20@163.com

    Not yet recruiting

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 411100

    Feng Huang, +86 18673420807, 18673420807@163.com

    Not yet recruiting

  • Ya'an People's Hospital

    Ya'an, Sichuan, 625000

    Jian Wang, +86 13550064528, wangjian0724@126.com

    Not yet recruiting

Other trials in China

About this study

Official title: Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events (TRACE-BRIDGE): A Multicenter, Randomized, Open-Label, Three-Arm, Blinded-Endpoint Phase III Trial

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain.

The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT.

Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

Read the detailed description

Mechanical thrombectomy (MT) has become the standard of care for eligible patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Randomized controlled trials and individual patient-level meta-analyses have demonstrated substantial improvements in functional outcomes with MT compared with medical management alone.

However, the optimal strategy for intravenous thrombolysis before mechanical thrombectomy remains uncertain. Previous randomized trials evaluating bridging thrombolysis have primarily investigated alteplase, and the additional clinical benefit of intravenous thrombolysis before MT compared with direct MT has not been conclusively established.

Tenecteplase and reteplase are two thrombolytic agents that may provide potential alternatives to alteplase in the bridging thrombolysis setting. Tenecteplase, administered at a dose of 0.25 mg/kg, has demonstrated promising efficacy and safety profiles in patients with acute ischemic stroke, with increasing evidence supporting its use as a bridging thrombolytic agent before MT. Reteplase, administered as two intravenous bolus doses of 18 mg, has also shown potential as an alternative thrombolytic agent and requires further evaluation in patients undergoing MT.

The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design). The trial will enroll adults with acute ischemic stroke who present within 4.5 hours of symptom onset and have imaging-confirmed anterior circulation large vessel occlusion. Participants must meet predefined eligibility criteria for intravenous thrombolysis and mechanical thrombectomy. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization.

The primary objective of the trial is to determine whether bridging thrombolysis with tenecteplase or reteplase, analyzed as a combined treatment strategy, is superior to direct mechanical thrombectomy alone in achieving functional independence at 90 days. If superiority is established, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

The planned sample size is 1,440 participants, with a maximum total sample size of 1,800 participants if sample size re-estimation is performed according to pre-specified criteria. An interim analysis is planned after approximately 60% of the originally planned sample size has been enrolled. The interim analysis will include a non-binding futility assessment and may include sample size re-estimation.

Being tested
rhTNK-tPA (0.25mg/kg), Reteplase 10 Units (U) plus a second dose of reteplase 10 U, No thrombolysis (thrombectomy alone)
Keywords
acute ischemic stroke, thrombolysis, thrombectomy, tenecteplase, reteplase
Medical subject headings
Ischemic Stroke, Brain Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhTNK-tPA (0.25mg/kg)Drug

    Also called Tenecteplase

    Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg/kg (maximum dose 25 mg) within 4.5 hours of symptom onset prior to mechanical thrombectomy.

  • Reteplase 10 Units (U) plus a second dose of reteplase 10 UDrug

    Also called rPA

    Two intravenous bolus injections of 18 mg each, administered within 4.5 hours of onset over approximately 2 minutes per bolus, separated by a 30-minute interval prior to thrombectomy. To avoid delays in reperfusion therapy, groin puncture and MT procedures may be initiated after administration of the first 18 mg bolus, without waiting for completion of the second bolus. Unless contraindicated, the second rPA bolus should be administered according to the scheduled dosing regimen irrespective of EVT status.

  • No thrombolysis (thrombectomy alone)Procedure or surgery

    Patients will undergo mechanical thrombectomy according to standard practice, without administration of intravenous thrombolytic agents.

Study groups in NCT07748039
Study groupRoleWhat they receive
rhTNK-tPA+MTExperimentalRecombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg/kg (maximum dose 25 mg) within 4.5 hours of symptom onset and prior to mechanical thrombectomy, followed by standard endovascular treatment.
Receives: Drug: rhTNK-tPA (0.25mg/kg)
rPA+MTExperimentalRecombinant human plasminogen activator derivative (rPA) administered as two intravenous bolus doses of 18 mg each, given over approximately 2 minutes per bolus and separated by a 30-minute interval. The first dose should be administered within 4.5 hours of symptom onset before mechanical thrombectomy. To avoid delays in reperfusion therapy, groin puncture and endovascular treatment may be initiated after administration of the first bolus without waiting for the second dose. The second bolus should be administered according to the prespecified dosing regimen unless contraindicated.
Receives: Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 U
MT aloneActive comparatorMechanical thrombectomy performed according to standard practice without administration of intravenous thrombolytic agents.
Receives: Procedure: No thrombolysis (thrombectomy alone)

What is being measured

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

  1. Functional Independence

    Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

    Measured: From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.

Secondary outcomes (19)

  1. Excellent functional outcome

    Proportion of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

    Measured: From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.

  2. Favorable functional outcome

    Proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 90 days after randomization. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.

    Measured: 90 days after randomization (±7 days), assessed by blinded outcome assessors.

  3. Early neurological improvement

    Proportion of participants achieving major early neurological recovery at 24 hours after randomization, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.

    Measured: 22-36 hours after randomization

  4. Neurological improvement

    Proportion of participants achieving neurological improvement at day 7 or discharge, whichever occurs first, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of ≥8 points or an NIHSS score of 0-1. The NIHSS ranges from 0 (no neurological deficit) to 42 (maximum neurological impairment), with higher scores indicating greater neurological impairment.

    Measured: Day 7 after randomization or discharge, whichever occurs first (±1 day)

  5. Pre-procedural recanalization

    Proportion of participants with successful reperfusion on initial diagnostic angiography before any endovascular device manipulation, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion.

    Measured: During the endovascular procedure, before endovascular device manipulation

  6. Near-complete reperfusion post endovascular treatment

    Proportion of participants achieving near-complete reperfusion at the end of the endovascular procedure, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2c or 3. The eTICI grade of 2c or 3 indicates near-complete to complete reperfusion, with residual perfusion defects limited to slow flow in a few distal cortical vessels or small distal cortical emboli.

    Measured: At the end of the endovascular procedure (immediately after completion of the procedure)

  7. Successful reperfusion post endovascular Treatment

    Proportion of participants achieving successful reperfusion at the end of the endovascular procedure, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion. An eTICI grade of 2b, 2c, or 3 indicates reperfusion of at least 50% of the affected vascular territory.

    Measured: At the end of the endovascular procedure (immediately after completion of the procedure)

  8. First-pass reperfusion

    Proportion of participants achieving near-complete reperfusion after the first thrombectomy pass, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2c or 3. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion. An eTICI grade of 2c or 3 represents near-complete or complete reperfusion, respectively.

    Measured: Immediately after the first thrombectomy pass during the endovascular procedure

  9. Modified first-pass reperfusion

    Proportion of participants achieving a modified first-pass effect, defined as successful reperfusion with an expanded Thrombolysis in Cerebral Infarction (eTICI) grade of 2b, 2c, or 3 after a single thrombectomy pass. The eTICI grading system is an angiographic scale used to assess reperfusion after endovascular therapy, ranging from 0 (no reperfusion) to 3 (complete reperfusion), with higher grades indicating greater reperfusion.

    Measured: Immediately after the first thrombectomy pass during the endovascular procedure

  10. Health Related Quality of Life

    Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire at 90 days after randomization. The EQ-5D-5L is a standardized instrument used to describe and value health status across five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems.

    Measured: 90 days after randomization (±7 days)

  11. Barthel index≥95

    Proportion of participants achieving a Barthel Index (BI) score of ≥95 at 90 days after randomization. The BI is a standardized scale used to assess activities of daily living and functional independence, ranging from 0 (complete dependence) to 100 (complete independence), with higher scores indicating greater functional ability.

    Measured: 90 days after randomization (±7 days)

  12. Symptomatic intracranial hemorrhage

    Symptomatic intracranial hemorrhage (sICH) based on modified Heidelberg Bleeding Classification intracranial hemorrhage on follow-up imaging associated with neurological deterioration (≥4-point increase in total NIHSS or ≥2-point increase in one NIHSS item), major medical intervention such as intubation, hemicraniectomy, external ventricular drainage, or death.

    Measured: Up to 36 hours from randomization

  13. Parenchymal Hematoma Type 2

    Proportion of participants with parenchymal hematoma type 2 (PH2), defined as a blood clot involving more than 30% of the infarcted area with substantial mass effect, according to the Heidelberg Bleeding Classification.

    Measured: Up to 36 hours from randomization

  14. Procedure-related complications

    Proportion of participants experiencing endovascular procedure-related complications, including vessel perforation, vessel dissection, distal embolization to a new territory (ENT), clinically significant vasospasm, access site complications, and contrast extravasation unrelated to vessel perforation.

    Measured: From the start of the endovascular procedure to 7 days after randomization

  15. Major Bleeding

    Proportion of participants experiencing major bleeding within 90 days after randomization, defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, including fatal bleeding, bleeding in a critical organ (e.g., intracranial, intraspinal, intraocular, or retroperitoneal bleeding), a fall in hemoglobin level of ≥2 g/dL, or transfusion of ≥2 units of red blood cells.

    Measured: 90 days after randomization (±7 days)

  16. Clinically relevant non-major bleeding

    Proportion of participants experiencing clinically relevant non-major bleeding (CRNMB) within 90 days after randomization, defined as bleeding that does not meet criteria for major bleeding but requires medical intervention, unscheduled medical evaluation, hospitalization, or close monitoring.

    Measured: 90 days after randomization (±7 days)

  17. All-cause mortality at 7 days

    Proportion of participants who died from any cause within 7 days after randomization.

    Measured: Within 7 days after randomization

  18. All-cause mortality at 90 days

    Proportion of participants who died from any cause within 90 days after randomization.

    Measured: 90 days after randomization (±7 days)

  19. Adverse events, serious adverse events, and suspected unexpected serious adverse reactions

    Proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs), or suspected unexpected serious adverse reactions (SUSARs) within 90 days after randomization.

    Measured: 90 days after randomization (±7 days)

Timeline

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

  1. First posted5 Aug 2026
  2. Study start16 Oct 2026
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Aug 2029 (estimated)

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748039
Sponsor's protocol ID
TRACEBRIDGE-2026-03
Other IDs
2025-A02
Acronym
TRACE- BRIDGE
Status last verified
Oct 2026
First submitted
26 Jul 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Butikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernandez-Perez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT Collaborators. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.

    PubMed 35810756

  • LeCouffe NE, Kappelhof M, Treurniet KM, Rinkel LA, Bruggeman AE, Berkhemer OA, Wolff L, van Voorst H, Tolhuisen ML, Dippel DWJ, van der Lugt A, van Es ACGM, Boiten J, Lycklama A Nijeholt GJ, Keizer K, Gons RAR, Yo LSF, van Oostenbrugge RJ, van Zwam WH, Roozenbeek B, van der Worp HB, Lo RTH, van den Wijngaard IR, de Ridder IR, Costalat V, Arquizan C, Lemmens R, Demeestere J, Hofmeijer J, Martens JM, Schonewille WJ, Vos JA, Uyttenboogaart M, Bokkers RPH, van Tuijl JH, Kortman H, Schreuder FHBM, Boogaarts HD, de Laat KF, van Dijk LC, den Hertog HM, van Hasselt BAAM, Brouwers PJAM, Bulut T, Remmers MJM, van Norden A, Imani F, Rozeman AD, Elgersma OEH, Desfontaines P, Brisbois D, Samson Y, Clarencon F, Krietemeijer GM, Postma AA, van Doormaal PJ, van den Berg R, van der Hoorn A, Beenen LFM, Nieboer D, Lingsma HF, Emmer BJ, Coutinho JM, Majoie CBLM, Roos YBWEM; MR CLEAN-NO IV Investigators. A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke. N Engl J Med. 2021 Nov 11;385(20):1833-1844. doi: 10.1056/NEJMoa2107727.

    PubMed 34758251

  • Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.

    PubMed 33464335

  • Suzuki K, Matsumaru Y, Takeuchi M, Morimoto M, Kanazawa R, Takayama Y, Kamiya Y, Shigeta K, Okubo S, Hayakawa M, Ishii N, Koguchi Y, Takigawa T, Inoue M, Naito H, Ota T, Hirano T, Kato N, Ueda T, Iguchi Y, Akaji K, Tsuruta W, Miki K, Fujimoto S, Higashida T, Iwasaki M, Aoki J, Nishiyama Y, Otsuka T, Kimura K; SKIP Study Investigators. Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke: The SKIP Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):244-253. doi: 10.1001/jama.2020.23522.

    PubMed 33464334

  • Mitchell PJ, Yan B, Churilov L, Dowling RJ, Bush SJ, Bivard A, Huo XC, Wang G, Zhang SY, Ton MD, Cordato DJ, Kleinig TJ, Ma H, Chandra RV, Brown H, Campbell BCV, Cheung AK, Steinfort B, Scroop R, Redmond K, Miteff F, Liu Y, Duc DP, Rice H, Parsons MW, Wu TY, Nguyen HT, Donnan GA, Miao ZR, Davis SM; DIRECT-SAFE Investigators. Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4.5 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):116-125. doi: 10.1016/S0140-6736(22)00564-5.

    PubMed 35810757

  • Majoie CB, Cavalcante F, Gralla J, Yang P, Kaesmacher J, Treurniet KM, Kappelhof M, Yan B, Suzuki K, Zhang Y, Li F, Morimoto M, Zhang L, Miao Z, Rinkel LA, Huang J, Otsuka T, Wang S, Davis S, Cognard C, Hong B, Coutinho JM, Song J, Chen W, Emmer BJ, Eker O, Zhang L, Dobrocky T, Nguyen HT, Bush S, Peng Y, LeCouffe NE, Takeuchi M, Han H, Matsumaru Y, Strbian D, Lingsma HF, Nieboer D, Yang Q, Meinel T, Mitchell P, Kimura K, Zi W, Nogueira RG, Liu J, Roos YB, Fischer U; IRIS collaborators. Value of intravenous thrombolysis in endovascular treatment for large-vessel anterior circulation stroke: individual participant data meta-analysis of six randomised trials. Lancet. 2023 Sep 16;402(10406):965-974. doi: 10.1016/S0140-6736(23)01142-X. Epub 2023 Aug 25.

    PubMed 37640037

  • 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.

    PubMed 36774935

  • 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.

    PubMed 29694815

  • Qiu Z, Li F, Sang H, Yuan G, Xie D, Zhou K, Li M, Meng Z, Kong Z, Ruan Z, Li C, Yang G, Wu J, Long C, Yang B, Hu H, Li Y, Luo J, Shi Z, Huang X, Jiang S, Yi T, Zeng G, Liu J, Luo X, Liu S, Chang M, Wu Y, Tang Y, Tian Z, Yan Z, Zhao H, Peng Y, Dai H, Zhou P, Li H, Liu W, Song D, Lei B, Xia Z, Tan X, Zhao M, Feng X, Cai L, Li Q, Wu Y, Jiang B, Tian Y, Li L, Jiang L, Long X, You F, Tao J, Zhou J, Wu D, Zheng C, Yin C, Wang D, Lu M, Albers GW, Nogueira RG, Campbell BCV, Nguyen TN, Saver JL, Zi W, Yang Q; BRIDGE-TNK Trial Investigators. Intravenous Tenecteplase before Thrombectomy in Stroke. N Engl J Med. 2025 Jul 10;393(2):139-150. doi: 10.1056/NEJMoa2503867. Epub 2025 May 21.

    PubMed 40396577

  • Li S, Gu HQ, Li H, Wang X, Jin A, Guo S, Lu G, Che F, Wang W, Wei Y, Wang Y, Li Z, Meng X, Zhao X, Liu L, Wang Y; RAISE Investigators. Reteplase versus Alteplase for Acute Ischemic Stroke. N Engl J Med. 2024 Jun 27;390(24):2264-2273. doi: 10.1056/NEJMoa2400314. Epub 2024 Jun 14.

    PubMed 38884332

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhTNK-tPA (0.25mg/kg), Reteplase 10 Units (U) plus a second dose of reteplase 10 U and No thrombolysis (thrombectomy alone) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Yongjun Wang at 5 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 10 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yongjun Wang, MD (+86 13911172565, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Independence (time frame: From randomization to 90 days after randomization (±7 days), with outcome assessment performed by blinded assessors.). 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 NCT07748039, which also lists 13 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 22 Oct 2026.

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