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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Danielle Dubenezic
- Numéro de téléphone: 732-897-8175
- E-mail: danielle.dubenezic@hmhn.org
Lieux d'étude
-
-
New Jersey
-
Neptune City, New Jersey, États-Unis, 07753
- Hackensack Meridian Health - Jersey Shore University Medical Center
-
Chercheur principal:
- Shadi Yaghi, MD
-
Contact:
- Danielle Dubenezic
- Numéro de téléphone: 732-897-8175
- E-mail: danielle.dubenezic@hmhn.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intravenous Tenecteplase (TNK)
Intravenous TNK 0.25 mg/Kg
|
Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
|
|
Comparateur placebo: Placebo
normal saline placebo
|
Placebo
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Efficacy of intravenous Tenecteplase (TNK)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patients with excellent functional outcome
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shadi Yaghi, MD, Hackensack Meridian Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ESTER-DOAC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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