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IntravenousPhase 4NCT06498323

Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT

A Phase 4 study testing tenecteplase in people with Intravenous and Thrombosis, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intravenous, Thrombosis, Acute Ischemic Stroke
What is being tested?
tenecteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteThailand
Study dates
3 Aug 2022to 31 Aug 2025
Phase
Phase 4
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

  • Diagnosed as Acute ischemic stroke within 4.5 hr of symptom onset
  • Age > 18 years old
  • No contraindication for thrombolytic drug
  • Informed consent from patients

Who cannot join

  • Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset
  • Have contraindication for thrombolytic drugs

Trial locations and contacts

1 site in 1 country.

Yongchai Nilanont contact

924245898

ynilanon@gmail.com

Thailand1 site, 1 recruiting

  • Siriraj Stroke Center,Siriraj Hospital

    Bangkok, 10700

    Yongchai Nilanont, 859398772, ynilanon@gmail.com

    Kanokkarn Wongmayurachat, 658794744, wkanokkarn@gmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial

Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 4.5 hours and without contraindications.

Tenecteplase, a genetically engineered tissue-type plasminogen activator, has been questioned to treat acute ischemic stroke instead of intravenous alteplase. Tenecteplase has more advantages over alteplase including higher fibrin specificity, longer half-life and easier to administer as a single intravenous bolus. The efficacy and safety of intravenous tenecteplase has been studied recently. In 2017, A phase 3 randomized open-label, blinded trial (NOR-TEST) 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients. A study in 2020, in the setting of acute large artery occlusion, Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10. Regarding safety concerns, tenecteplase showed no significant higher incidence of intracerebral hemorrhage. Administration, tenecteplase might be better in the setting of the case on mobile stroke units. Assuming, earlier reperfusion by thrombolytic drug may have improved patient's neurologic outcomes. We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 4.5 hours after symptom onset.

Being tested
tenecteplase
Keywords
Acute ischemic stroke, Mobile stroke unit, Intravenous Tenecteplase
Medical subject headings
Thrombosis, Ischemic Stroke

What participants receive

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

  • tenecteplaseDrug

    Intravenous thrombolytic agents administration

Study groups in NCT06498323
Study groupRoleWhat they receive
tenecteplaseExperimentalIntravenous tenecteplase (0.25mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.
Receives: Drug: tenecteplase
alteplaseActive comparatorIntravenous alteplase (0.9mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.
Receives: Drug: tenecteplase

What is being measured

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

  1. mRS Score

    mRS Score

    Measured: at 3 months

Secondary outcomes (1)

  1. NIHSS Score at 24 hrs

    NIHSS Score at 24 hrs after intravenous tenecteplase

    Measured: at 24 hours

Timeline

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

  1. First posted12 Jul 2024
  2. Study start3 Aug 2022
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2025 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498323
Sponsor's protocol ID
376/2565(IRB1)
Status last verified
Jul 2024
First submitted
13 Jun 2022
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
No
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, 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

  • 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

  • Haley 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 20185783

  • Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.

    PubMed 22435369

  • 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

  • Nepal G, Kharel G, Ahamad ST, Basnet B. Tenecteplase versus Alteplase for the Management of Acute Ischemic Stroke in a Low-income Country-Nepal: Cost, Efficacy, and Safety. Cureus. 2018 Feb 9;10(2):e2178. doi: 10.7759/cureus.2178.

    PubMed 29651371

  • Muir KW. Should Tenecteplase Replace Alteplase for Acute Thrombolysis? Stroke. 2021 Mar;52(3):1091-1093. doi: 10.1161/STROKEAHA.120.033593. Epub 2021 Feb 16. No abstract available.

    PubMed 33588587

  • Ronning OM, Logallo N, Thommessen B, Tobro H, Novotny V, Kvistad CE, Aamodt AH, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase Versus Alteplase Between 3 and 4.5 Hours in Low National Institutes of Health Stroke Scale. Stroke. 2019 Feb;50(2):498-500. doi: 10.1161/STROKEAHA.118.024223.

    PubMed 30602354

  • Katsanos AH, Safouris A, Sarraj A, Magoufis G, Leker RR, Khatri P, Cordonnier C, Leys D, Shoamanesh A, Ahmed N, Alexandrov AV, Tsivgoulis G. Intravenous Thrombolysis With Tenecteplase in Patients With Large Vessel Occlusions: Systematic Review and Meta-Analysis. Stroke. 2021 Jan;52(1):308-312. doi: 10.1161/STROKEAHA.120.030220. Epub 2020 Dec 4.

    PubMed 33272127

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tenecteplase in people with Intravenous and Thrombosis, run by Mahidol University at 1 site in Thailand.

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 4 inclusion and 2 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Yongchai Nilanont (924245898, ynilanon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mRS Score (time frame: at 3 months). 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 NCT06498323, which also lists 10 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 12 Jul 2024.

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