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

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