Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Danielle Dubenezic
- Telefoonnummer: 732-897-8175
- E-mail: danielle.dubenezic@hmhn.org
Studie Locaties
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New Jersey
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Neptune City, New Jersey, Verenigde Staten, 07753
- Hackensack Meridian Health - Jersey Shore University Medical Center
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Hoofdonderzoeker:
- Shadi Yaghi, MD
-
Contact:
- Danielle Dubenezic
- Telefoonnummer: 732-897-8175
- E-mail: danielle.dubenezic@hmhn.org
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intravenous Tenecteplase (TNK)
Intravenous TNK 0.25 mg/Kg
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Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
|
|
Placebo-vergelijker: Placebo
normal saline placebo
|
Placebo
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Efficacy of intravenous Tenecteplase (TNK)
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patients with excellent functional outcome
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Shadi Yaghi, MD, Hackensack Meridian Health
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ESTER-DOAC
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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