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tenecteplase · 1 trial · 1 indication
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.
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
| Arm | Type | Description |
|---|---|---|
| Intravenous Tenecteplase (TNK) | EXPERIMENTAL | Intravenous TNK 0.25 mg/Kg |
| Placebo | PLACEBO_COMPARATOR | normal saline placebo |
| Name | Type | Description |
|---|---|---|
| Intravenous tenecteplase (TNK) | DRUG | Intravenous administration of tenecteplase (TNK) at 0.25 mg/kg for a maximum dose of 25 mg. |
| Placebo | DRUG | Placebo |
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, riv...