Method of treating stroke with thrombolytic agent

Abstract

A method for treating acute ischemic stroke in a human comprises administering tenecteplase to the human in a total dose of about 0.05 to 0.5 mg/kg, given as (a) an initial bolus dose of about 0.015 to 0.15 mg/kg, followed by infusion of an amount equaling the total dose minus the initial dose over a period of about 50-90 minutes, or (b) a bolus. Also described are kits for carrying out this method.

1 . A method for treating acute ischemic stroke in a human comprising administering tenecteplase to the human in a total dose of about 0.05 to 0.5 mg/kg, given as (a) an initial bolus dose of about 0.05 to 0.15 mg/kg, followed by infusion of an amount equaling the total dose minus the initial dose over a period of about 50-90 minutes, or (b) a bolus.  
     
     
         2 . The method of  claim 1  wherein the total dose is about 0.2 to 0.3 mg/kg.  
     
     
         3 . The method of  claim 1  or  2  wherein the total dose is about 0.25 mg/kg.  
     
     
         4 . The method of any one of claims  1 - 3  wherein the total dose is given as an initial bolus followed by the infusion.  
     
     
         5 . The method of any one of claims  1 - 4  wherein the initial dose is about 0.08 to 0.12 mg/kg bolus.  
     
     
         6 . The method of any one of claims  1 - 5  wherein the initial dose is about 0.1 mg/kg bolus.  
     
     
         7 . The method of any one of claims  1 - 6  wherein the period of infusion is about 55-70 minutes.  
     
     
         8 . The method of any one of claims  1 - 7  wherein the period of infusion is about 60 minutes.  
     
     
         9 . The method of any one of claim  1 - 8  wherein the total dose is about 0.25 mg/kg, given as an initial bolus of about 0.1 mg/kg, followed by infusion of about 0.15 mg/kg over about 60 minutes.  
     
     
         10 . The method of any one of claims  1 - 3  wherein the total dose is given as a bolus.  
     
     
         11 . The method of any one of claims  1 - 10  wherein the tenecteplase is administered to the human at a time between about 15 minutes and 20 hours from the onset of acute ischemic stroke.  
     
     
         12 . The method of any one of claims  1 - 11  wherein the tenecteplase is administered to the human at a time between about 30 minutes and 6 hours from the onset of acute ischemic stroke.  
     
     
         13 . The method of any one of claims  1 - 12  wherein the tenecteplase is administered to the human at a time between about 30 minutes and 3 hours from the onset of acute ischemic stroke.  
     
     
         14 . The method of any one of claims  1 - 13  wherein the bolus is intravenous.  
     
     
         15 . The method of any one of claims  1 - 14  further comprising administering to the human an effective amount of a second medicament, wherein the first medicament is tenecteplase.  
     
     
         16 . The method of  claim 15  wherein the second medicament is a neuroprotective agent, a thrombolytic agent, a glycoprotein IIb IIIa antagonist, or an anti-CD18 antibody.  
     
     
         17 . A kit comprising: 
 (a) a container comprising tenecteplase; and    (b) instructions for using the tenecteplase to treat acute ischemic stroke in a human by administering the tenecteplase to the human in a total dose of about 0.05 to 0.5 mg/kg, given as (a) an initial bolus dose of about 0.05 to 0.15 mg/kg, followed by infusion of an amount equaling the total dose minus the initial dose over a period of about 50-90 minutes, or (b) a bolus.    
     
     
         18 . The kit of  claim 17  wherein the total dose is about 0.2 to 0.3 mg/kg.  
     
     
         19 . The kit of  claim 17  or  18  wherein the total dose is about 0.25 mg/kg.  
     
     
         20 . The kit of any one of claims  17 - 19  wherein the total dose is given as an initial bolus followed by the infusion.  
     
     
         21 . The kit of any one of claims  17 - 20  wherein the initial bolus dose is about 0.08 to 0.12 mg/kg.  
     
     
         22 . The kit of any one of claims  17 - 21  wherein the total dose is about 0.25 mg/kg, given as an initial bolus of about 0.1 mg/kg, followed by infusion of about 0.15 mg/kg over about 60 minutes.  
     
     
         23 . The kit of any one of claims  17 - 19  wherein the total dose is given as a bolus.  
     
     
         24 . The kit of any one of claims  17 - 23  further comprising a container comprising a second medicament, wherein the instructions include instructions for using the second medicament in combination with the tenecteplase to treat ischemic stroke in a human by administering to the human an effective amount of the second medicament.  
     
     
         25 . The kit of  claim 24  wherein the second medicament is a neuroprotective agent, a thrombolytic agent, a glycoprotein IIb IIIa antagonist, or an anti-CD18 antibody.