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Not yet recruiting NCT07621796

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

Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous tenecteplase (TNK), Placebo.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)

Overview

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.

Interventions

  • Drug Intravenous tenecteplase (TNK)
    Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
  • Drug Placebo
    Placebo

Primary outcome measures

  • Efficacy of intravenous Tenecteplase (TNK) [Time frame: 90 days post administration]
  • Safety of intravenous TNK [Time frame: within 36 hours from thrombolysis administration]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hackensack Meridian Health - Jersey Shore University Medical Center — Neptune City

Identifiers

NCT: NCT07621796 · ESTER-DOAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗