Method of preventing of systemic-to-pulmonary-artery shunt thrombosis

Abstract

The present invention is directed to the use of cangrelor for the treatment and/or prevention of shunt thrombosis in patients suffering congenital heart diseases undergoing shunt surgery. The invention is also directed to the use of cangrelor for the treatment and/or prevention of stent thrombosis in pediatric patients undergoing stent implantation.

1 . A method of treating or preventing shunt thrombosis in a patient comprising administering a pharmaceutical composition comprising cangrelor to the patient wherein the patient is suffering from congenital heart diseases. 
     
     
         2 . The method of  claim 1  wherein the patient is undergoing shunt surgery. 
     
     
         3 . The method of  claim 2  wherein the shunt surgery is selected from the group consisting of systemic-to-pulmonary artery shunt, Blalock-Taussing shunt, central shunt, and right ventricle to pulmonary artery palliative shunts. 
     
     
         4 . The method of  claim 3  wherein the shunt surgery is systemic-to-pulmonary artery shunt surgery. 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 1  wherein the patient is undergoing shunt surgery or stent implantation. 
     
     
         7 . The method of  claim 6  wherein the shunt surgery or stent implantation is selected from the group consisting of systemic-to-pulmonary artery shunt, Blalock-Taussing shunt, central shunt, right ventricle to pulmonary artery palliative shunt, and ductus arterious stent. 
     
     
         8 . The method of  claim 7  wherein the patients suffer single ventricle physiology palliated with systemic-to-pulmonary artery shunt. 
     
     
         9 . The method of  claims 1  wherein the administration is intravenous. 
     
     
         10 . The method of  claim 1  wherein the intravenous administration is a continuous infusion. 
     
     
         11 . The method of  claim 10  wherein the amount of cangrelor administered is between about 0.1 and about 4 μg/kg/min. 
     
     
         12 . The method of  claim 11  wherein the amount of cangrelor administered is between about 0.1 μg/kg/min and about 1.5 μg/kg/min. 
     
     
         13 . The method of  claim 12 , wherein the point in time when the pharmaceutical composition is administered is between about half an hour and about 24 hours from the termination of the shunt surgery or stent implantation. 
     
     
         14 . The method of  claim 13 , wherein the point in time when the pharmaceutical composition is administered is between about 2 and about 4 hours from the termination of the shunt surgery or stent implantation. 
     
     
         15 . A method for preventing and/or treatment of shunt or stent thrombosis comprising:
 i) performing the shunt surgery or stent implantation; and   ii) administering a composition comprising cangrelor after the surgery.   
     
     
         16 . The method according to  claim 15  wherein the composition is administered as a bolus, or as a continuous infusion, or as a bolus followed by a continuous infusion, or as a continuous infusion followed by a bolus. 
     
     
         17 . The method according to  claim 15  wherein the composition is administered as a continuous infusion for at least about 10 minutes to about 72 hours or until administration of an oral agent for prevention of platelet aggregation. 
     
     
         18 . The method according to  claim 17  wherein the composition is administered as a continuous infusion for at least about 10 minutes to about 2 hours. 
     
     
         19 . A method of treatment of a patient comprising administering a pharmaceutical composition comprising cangrelor to the patient wherein the patient is undergoing shunt surgery or shunt implantation and then administering oral antiplatelet therapies to the patient. 
     
     
         20 . The method of  claim 19  wherein the shunt surgery or stent implantation is selected from the group consisting of systemic-to-pulmonary artery shunt, Blalock-Taussing shunt, central shunt, right ventricle to pulmonary artery palliative shunt, and ductus arterious stent. 
     
     
         21 . The method of  claim 20  wherein the administration further comprising:
 i) the administering a continuous infusion of cangrelor after shunt surgery or stent implantation for at least one hour or longer; 
 ii) discontinuing the treatment with cangrelor; and 
 iii) administering the oral antiplatelet therapy. 
 
     
     
         22 . The method of  claim 21  wherein the continuous infusion of cangrelor is at dosage between about 0.1 and about 4 μg/kg/min. 
     
     
         23 . The method of  claim 22  wherein the continuous infusion is between about 0.1 and about 1.5 μg/kg/min. 
     
     
         24 . The method of  claim 22  wherein the continuous infusion is between about 0.1 and about 1 μg/kg/min. 
     
     
         25 . The method of  claim 22  wherein the continuous infusion is between about 0.1 and about 0.5 μg/kg/min. 
     
     
         26 . The method of  claim 22  wherein the continuous infusion is between about 0.1 and about 0.3 μg/kg/min. 
     
     
         27 . (canceled)