Tenecteplase for stroke in people who recently took a blood thinner pill
Tests tenecteplase against placebo in adults with ischemic stroke who recently took anticoagulants.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
Key facts
- Where
- Neptune City, United StatesSee the site
- Phase
- Phase 3
Where in United States
- Hackensack Meridian Health Jersey Shore University Medical CenterNeptune City, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hackensack Meridian Health
- Trial code
- NCT07621796
- Record updated
- 2 June 2026
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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: Surgery within 2 weeks; Intracranial or intraspinal surgery within 3 months; 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); Current or history of intracerebral hemorrhage; Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks; Major head trauma or ischemic stroke within 3 months; Comorbid condition with life expectancy of less than 3 months; Any condition that precludes thrombolytic therapy as determined by site principal investigator; 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; Advanced kidney disease (eGFR < 30 ml/min); Known thrombocytopenia (platelets < 100,000); Non-disabling deficits; ASPECTS < 6 or clear hypodensity on CT suggestive of completed infarct; Known or suspected aortic dissection; Known or high suspicion for infective endocarditis; Intracranial neoplasm, arterio-venous malformation, or cavernous malformation; Pregnancy.