NCT07621796Not yet recruitingPhase 3
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 26 May 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 30 Jan 2032
- Lead sponsor
- Hackensack Meridian Health
- Diseases
- Stroke
- NCT number
- NCT07621796
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 660
- From 1 Jan 2027 to the primary completion date, 30 Jan 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hackensack Meridian Health Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.