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Also known as Intravenous tenecteplase (TNK)
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...
Tenecteplase is an investigational small molecule being studied for the treatment of acute ischemic stroke. It is currently in Phase 3 clinical development. The drug is administered intravenously and is being evaluated in patients who have recently ingested a direct oral anticoagulant.
Tenecteplase is a small molecule being developed for acute ischemic stroke. Its specific molecular target has not been disclosed. The drug is being studied for its efficacy and safety in patients with acute ischemic stroke who have recently taken a direct oral anticoagulant.
Tenecteplase is being developed by Meridian Bioscience Inc, a company traded under the ticker symbol VIVO. The drug is currently in Phase 3 clinical development for the treatment of acute ischemic stroke.
Tenecteplase is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating the drug's efficacy and safety in patients with acute ischemic stroke.
Tenecteplase is being studied in a Phase 3 clinical trial with the identifier NCT07621796. This randomized, double-blind, placebo-controlled trial is enrolling 660 participants in the United States. The trial is evaluating the efficacy and safety of tenecteplase in acute ischemic stroke patients who have recently ingested a direct oral anticoagulant.
Yes, tenecteplase is also known as intravenous tenecteplase (TNK). The drug is being studied in a Phase 3 clinical trial for acute ischemic stroke, with the trial identifier NCT07621796.