Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)
Hackensack Meridian Health
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). 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugIntravenous tenecteplase (TNK)
Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
- DrugPlacebo
Placebo
Location
- Hackensack Meridian Health - Jersey Shore University Medical CenterNeptune City, New Jersey