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Tenecteplase for Stroke Patients on Blood Thinners

This study is testing if intravenous tenecteplase (TNK) can help people experiencing an acute ischemic stroke (a stroke caused by a blood clot) who have recently taken certain blood thinners called Direct Oral Anticoagulants (DOACs). You might be able to join if you are an adult (18 or older) with a suspected acute ischemic stroke, can receive treatment within 4.5 hours of your last known well time, and have taken a DOAC within the last 48 hours. The study aims to see how effective tenecteplase is at 90 days after treatment and to check its safety within 36 hours. Participants will either receive tenecteplase or a placebo (an inactive substance) and will be followed for 90 days.

Study design
This is an interventional study planning to enroll 660 participants. Participants will be randomly assigned to receive either tenecteplase or a placebo.
What's involved
Participants will receive either tenecteplase or a placebo. They will be followed for 90 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after receiving treatment to assess the effectiveness of tenecteplase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07621796

Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Hackensack Meridian Health
~660 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Intravenous tenecteplase (TNK)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of intravenous Tenecteplase (TNK)
Measured over 90 days post administration
+1 more outcome measured

Conditions

Acute Ischemic Stroke

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NCT07621796

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hackensack Meridian Health - Jersey Shore University Medical Center

    Neptune City, New Jerseystudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shadi Yaghi, MD · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health

Who to contact

Danielle Dubenezic
[email protected]
732-897-8175
Email the study team

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Eligibility criteria

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

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

What this trial measures

  • Efficacy of intravenous Tenecteplase (TNK)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 TNKwithin 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