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Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)

26. maj 2026 opdateret af: Hackensack Meridian Health

Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)

The study will randomize patients with acute ischemic stroke and Direct Oral AntiCoagulants (DOAC) ingestion within 48 hours from enrollment (but otherwise eligible for thrombolysis) to administration of intravenous tenecteplase vs. placebo (1:1).

Participants will be enrolled at NIH StrokeNet sites across the US and followed for 90-days.

The primary aim is to determine the efficacy of intravenous tenecteplase (TNK) vs placebo among acute ischemic stroke patients and to determine the safety of TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis. Efficacy and safety endpoints will be the focus of this proposed Phase III study.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

660

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • New Jersey
      • Neptune City, New Jersey, Forenede Stater, 07753
        • Hackensack Meridian Health - Jersey Shore University Medical Center
        • Ledende efterforsker:
          • Shadi Yaghi, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults (18 years or older) with a suspected acute ischemic stroke and clearly disabling deficits
  • Presenting within 4.5 hours of last known well
  • Able to initiate intravenous thrombolysis within 4.5 hours of last known well
  • On recent DOAC therapy (dabigatran, apixaban, rivaroxaban, edoxaban) and known last dose taken within 48 hours from thrombolysis.

Exclusion Criteria:

  • Current or history of intracerebral hemorrhage
  • Non-disabling deficits
  • Bleeding disorder (e.g. hemophilia) or advanced liver disease or known INR > 1.7 within 6 hours
  • Use of therapeutic low molecular weight heparin or therapeutic dose heparin with elevated PTT
  • ASPECTS < 6 or clear hypodensity on CT suggestive of completed infarct
  • Advanced kidney disease (eGFR < 30 ml/min)
  • Known or suspected aortic dissection
  • Known or high suspicion for infective endocarditis
  • Surgery within 2 weeks
  • Intracranial or intraspinal surgery within 3 months
  • Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks
  • Intracranial neoplasm, arterio-venous malformation, or cavernous malformation
  • Major head trauma or ischemic stroke within 3 months
  • Known thrombocytopenia (platelets < 100,000)
  • Planned endovascular treatment within 30 minutes of study drug administration (i.e., consent, randomization and administration of study drug must occur at least 30 minutes prior to groin puncture; standard care is not to be delayed and patients in whom endovascular therapy will start sooner will not be enrolled)
  • Comorbid condition with life expectancy of less than 3 months
  • Any condition that precludes thrombolytic therapy as determined by site principal investigator
  • Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intravenous Tenecteplase (TNK)
Intravenous TNK 0.25 mg/Kg
Medicin: Intravenous tenecteplase (TNK)
Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
Placebo komparator: Placebo
normal saline placebo
Medicin: Placebo
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of intravenous Tenecteplase (TNK)
Tidsramme: 90 days post administration

Determine the efficacy of intravenous Tenecteplase (TNK) vs placebo among acute ischemic stroke patients within 4.5 hours of their last known well who used DOAC within 48 hours prior to thrombolysis.

The primary endpoint is 90-day modified Rankin Scale (mRS). Modified Rankin Scale is a 6 point tool to assess disability with 0 being no disability and 6 being death.
90 days post administration
Safety of intravenous TNK
Tidsramme: within 36 hours from thrombolysis administration

Determine the safety of intravenous TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis.

The primary safety endpoint is symptomatic intracranial hemorrhage (sICH) sICH is defined as any hemorrhage with neurological deterioration in the form of ≥ 4 points increase in the NIHSS, or that leads to death and is identified as the predominant cause of the neurologic deterioration (ECASS III definition) and occurring within 36 hours from thrombolysis administration
within 36 hours from thrombolysis administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients with excellent functional outcome
Tidsramme: 90 days post administration

To compare the percentage of patients with excellent functional outcome (mRS 0-1) between intravenous TNK versus placebo.

mRS 0-1 at 90-days The endpoint of mRS 0-1 at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
90 days post administration
Patients with good functional outcome
Tidsramme: 90 days post administration

To compare the percentage of patients with good functional outcome (mRS 0-2) between intravenous TNK versus placebo.

mRS 0-2 at 90-days The endpoint of mRS 0-2 at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
90 days post administration
Utility weighted mRS between intravenous TNK versus placebo
Tidsramme: 90 days post administration
To compare the utility weighted mRS between intravenous TNK versus placebo. Utility weighted mRS The endpoint of Utility mRS at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
90 days post administration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hackensack Meridian Health

Efterforskere

  • Ledende efterforsker: Shadi Yaghi, MD, Hackensack Meridian Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

30. januar 2032

Studieafslutning (Anslået)

30. januar 2032

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ESTER-DOAC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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