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Stroke, AcutePhase 2/3BRIDGE-TNKNCT04733742

Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke

A Phase 2/3 study testing rhTNK-tPA and Endovascular treatment in people with Stroke, Acute and Stroke, Ischemic, run by Xinqiao Hospital of Chongqing at 6 sites in China.

Completed

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

Official record
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Trial summary

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute, Stroke, Ischemic
What is being tested?
rhTNK-tPA and Endovascular treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
6 sitesChina
Study dates
9 May 2022to 7 Feb 2025
Phase
Phase 2/3
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

  • Aged 18 years or older;
  • Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
  • No significant prestroke functional disability: for age <80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
  • MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
  • EVT is planned by clinical care team;
  • Written informed consent is obtained from patients and/or their legal representatives.

Who cannot join

  • Intracranial hemorrhage on baseline CT or MR
  • Contraindication to intravenous thrombolytics
  • Already received intravenous thrombolytic after index stroke
  • Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
  • Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
  • Current participation in another investigational drug clinical trial
Show all 13Show fewer
  • Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
  • Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
  • Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
  • Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
  • Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
  • Any terminal disease with a life expectancy less than half a year
  • Unlikely to be available for follow-up at 90 days.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Xinqiao Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • The First Affiliated Hospital, Hengyang Medical School, University of South China

    Hengyang, Hunan

  • The Second Hospital of Jiaozuo

    Jiaozuo, Henan

  • Wuhan No. 1 Hospital

    Wuhan, Hubei, 430000

  • The 904th Hospital of CPLA

    Wuxi, Jiangsu, 214000

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 525000

Other trials in China

About this study

Official title: Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

Read the detailed description

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Being tested
rhTNK-tPA, Endovascular treatment
Keywords
Thrombolysis, Endovascular treatment, rhTNK-tPA
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • rhTNK-tPADrug

    Also called TNKase, TNK-tPA

    intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment

  • Endovascular treatmentOther

    Also called intra-arterial treatment, interventional therapy

    endovascular treatment

Study groups in NCT04733742
Study groupRoleWhat they receive
Conbined treatment groupExperimentalintravenous tenecteplase bridging with endovascular treatment
Receives: Drug: rhTNK-tPA; Other: Endovascular treatment
Endovascular treatment alone groupActive comparatorendovascular treatment alone
Receives: Other: Endovascular treatment

What is being measured

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

  1. Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

    functional independence

    Measured: 90 days

Secondary outcomes (14)

  1. Substantial reperfusion at initial angiogram

    evaluate effect of tenecteplase on reperfusion

    Measured: within 5 minutes at initial angiogram

  2. Successful reperfusion at end-of-procedure angiography

    evaluate vascular patency after thrombectomy

    Measured: 15 minutes after initial angiogram

  3. First-pass reperfusion

    defined as Expanded Treatment in Cerebral Infarction ≥2c after the first thrombectomy pass

    Measured: After artery puncture, but before thrombectomy

  4. Modified first-pass reperfusion

    defined as Expanded Treatment in Cerebral Infarction ≥2b after the first thrombectomy pass

    Measured: After artery puncture, but before thrombectomy

  5. National Institutes of Health Stroke Scale (NIHSS) score

    Neurological status

    Measured: 5 to 7 days or discharge

  6. modified Rankin scale score

    disability level

    Measured: 90 days

  7. Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)

    excellent outcome

    Measured: 90 days

  8. Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)

    ambulatory or bodily needs-capable or better

    Measured: 90 days

  9. Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)

    Health-related quality of life

    Measured: 90 days

  10. Any radiologic intracranial hemorrhage within 48 hours

    evaluate intracranial hemorrhage

    Measured: within 48 hours after endovascular treatment

  11. Symptomatic intracranial hemorrhage within 48 hours

    evaluate intracranial hemorrhage (Heidelberg classification)

    Measured: within 48 hours after endovascular treatment

  12. Mortality within 90 days

    evaluate death rate of the two treatment groups

    Measured: 90 days

  13. Procedural-related complications

    evaluate complications

    Measured: within 90 days

  14. Severe adverse events

    evaluate any adverse events

    Measured: within 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 posted2 Feb 2021
  2. Study start9 May 2022
  3. Primary completion16 Dec 2024
  4. Study completion7 Feb 2025

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733742
Sponsor's protocol ID
BRIDGE-TNK
Acronym
BRIDGE-TNK
Status last verified
Mar 2025
First submitted
26 Jan 2021
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study data without patient information

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

  • Mai LM, Oczkowski W. Tenecteplase before thrombectomy for ischemic stroke improved reperfusion compared with alteplase. Ann Intern Med. 2018 Aug 21;169(4):JC20. doi: 10.7326/ACPJC-2018-169-4-020. No abstract available.

    PubMed 30128510

  • 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

  • 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

  • Huang X, Xu J, Saver JL, Xu H, Yuan G, Kong Z, Ruan Z, Li C, Yang G, Albers GW, Nguyen TN, Sang H, Qiu Z, Yang Q, Zhou Z, Li Z. Effect of Baseline ASPECTS on Tenecteplase Efficacy Before Thrombectomy in Acute Large-Vessel Occlusion Stroke: A Post Hoc Analysis of the BRIDGE-TNK Randomized Trial. Neurology. 2026 Sep 22;107(6):e218467. doi: 10.1212/WNL.0000000000218467. Epub 2026 Aug 20.

    PubMed 42623571

  • 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

  • Qiu Z, Li F, Xie D, Yuan G, Nguyen TN, Zhou K, Nogueira RG, Saver JL, Campbell BCV, Albers GW, Sang H, Li L, Tian Y, Meng Z, Wang D, Zi W, Yang Q; BRIDGE-TNK investigators. Efficacy and Safety of Intravenous Tenecteplase Before Endovascular Thrombectomy for Acute Ischemic Stroke: The Multicenter, Randomized, BRIDGE-TNK Trial Protocol. J Am Heart Assoc. 2024 Nov 5;13(21):e036765. doi: 10.1161/JAHA.124.036765. Epub 2024 Oct 22.

    PubMed 39435713

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing rhTNK-tPA and Endovascular treatment in people with Stroke, Acute and Stroke, Ischemic, run by Xinqiao Hospital of Chongqing at 6 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 13 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Proportion of patients functionally independent (mRS score 0 to 2) at 90 days (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 NCT04733742, which also lists 7 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 3 Apr 2025.

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