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.
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.
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