Acute Ischemic StrokePhase 3ESTER-DOACNCT07621796
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
A Phase 3 study testing Intravenous tenecteplase (TNK) in people with Acute Ischemic Stroke, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intravenous tenecteplase (TNK)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jan 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hackensack Meridian Health - Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Danielle Dubenezic, 732-897-8175, danielle.dubenezic@hmhn.org
Shadi Yaghi, MD
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intravenous tenecteplase (TNK), Placebo
- Keywords
- acute ischemic stroke, Oral AntiCoagulants, thrombolysis, intravenous tenecteplase administration
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous tenecteplase (TNK)Drug
Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Tenecteplase (TNK) | Experimental | Intravenous TNK 0.25 mg/Kg Receives: Drug: Intravenous tenecteplase (TNK) |
| Placebo | Placebo comparator | normal saline placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of intravenous Tenecteplase (TNK)
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.
Measured: 90 days post administration
Safety of intravenous TNK
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
Measured: within 36 hours from thrombolysis administration
Secondary outcomes (3)
Patients with excellent functional outcome
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
Measured: 90 days post administration
Patients with good functional outcome
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
Measured: 90 days post administration
Utility weighted mRS between intravenous TNK versus placebo
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
Measured: 90 days post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jan 2032 (estimated)
- Study completion30 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shadi Yaghi, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621796
- Sponsor's protocol ID
- ESTER-DOAC
- Acronym
- ESTER-DOAC
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)
- ClinicalTrials.gov ID
- NCT07621796
- Acronym / sponsor ID
- ESTER-DOAC / ESTER-DOAC
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, Oral AntiCoagulants, thrombolysis, intravenous tenecteplase administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jan 2032 (estimated)
- Study completion
- 30 Jan 2032 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Tenecteplase (TNK) | Experimental | Drug: Intravenous tenecteplase (TNK)Intravenous TNK 0.25 mg/Kg |
| Placebo | Placebo comparator | Drug: Placebonormal saline placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous tenecteplase (TNK)Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg. | Drug | Intravenous Tenecteplase (TNK) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Efficacy of intravenous Tenecteplase (TNK)
Time frame: 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.
Safety of intravenous TNK
Time frame: 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
3 secondary outcomes
Patients with excellent functional outcome
Time frame: 90 days post administration
Patients with good functional outcome
Time frame: 90 days post administration
Utility weighted mRS between intravenous TNK versus placebo
Time frame: 90 days post administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shadi Yaghi, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous tenecteplase (TNK) in people with Acute Ischemic Stroke, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Dubenezic (732-897-8175, danielle.dubenezic@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intravenous Tenecteplase (TNK) (time frame: 90 days post administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.