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
Parallel
Intravenous tenecteplase (TNK)
DrugIntravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg.
Placebo
DrugPlacebo
Efficacy of intravenous Tenecteplase (TNK)
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 TNK
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
Patients with excellent functional outcome
To compare the percentage of patients with excellent functional outcome (mRS 0-1) between intravenous TNK versus placebo. mRS 0-1 at 90-days The endpoint of mRS 0-1 at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
Patients with good functional outcome
To compare the percentage of patients with good functional outcome (mRS 0-2) between intravenous TNK versus placebo. mRS 0-2 at 90-days The endpoint of mRS 0-2 at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
Utility weighted mRS between intravenous TNK versus placebo
To compare the utility weighted mRS between intravenous TNK versus placebo. Utility weighted mRS The endpoint of Utility mRS at 90 days is a standard outcome used in stroke trials to measure functional improvements after acute treatments such as thrombolysis and endovascular treatment
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
