Method of preventing of systemic-to-pulmonary-artery shunt thrombosis
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Publication Number
US-12502400-B2
Publication Date
2025-12-23
Expiration Date
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.
Core Innovation
The invention relates to a method of treating shunt thrombosis or stent implantation in a pediatric patient suffering from a congenital heart disease by administering a pharmaceutical composition comprising cangrelor. The cangrelor is administered within about half an hour to about 24 hours after termination of a procedure on the patient, where the procedure is shunt surgery or stent implantation.
The invention addresses a problem of high postoperative thrombotic risk after systemic-to-pulmonary artery shunt surgery and the risk of stent thrombosis in pediatric patients with congenital heart disease. It describes an unmet need for preventing and/or treating shunt thrombosis and stent thrombosis in this setting before aspirin therapy, which is typically administered about 12–24 hours after surgery.
The invention supports the use of cangrelor as a rapid, reversible P2Y12 receptor antagonist suitable for bridging around the peri-procedural period. It further describes early phase clinical PK/PD in neonates with congenital heart disease using intravenous infusion regimens, indicating rapid reversibility and platelet inhibition as measured by LTA and microfluidics.
Claims Coverage
The document contains one independent claim with dependent claims refining key inventive features. Across the claim set, the inventive features focus on the patient population, the indication, the post-procedure administration time window, and cangrelor administration mode and dose-rate constraints.
Cangrelor treatment of pediatric congenital heart disease shunt thrombosis or stent implantation
Administering a pharmaceutical composition comprising cangrelor to treat shunt thrombosis or stent implantation in a pediatric patient suffering from a congenital heart disease.
Post-procedure administration between about half an hour and about 24 hours
Administering the pharmaceutical composition between about half an hour and about 24 hours after termination of a procedure on the patient, where the procedure is shunt surgery or stent implantation.
Cangrelor administration after shunt surgery selected from defined shunt surgery subtypes
Where the procedure is shunt surgery, selecting the shunt surgery from systemic-to-pulmonary artery shunt surgery, Blalock-Taussing shunt surgery, central shunt surgery, or right ventricle to pulmonary artery palliative shunts surgery.
Intravenous continuous infusion
Administering the pharmaceutical composition as an intravenous continuous infusion.
Cangrelor dose-rate between about 0.1 and about 4 μg/kg/min
Administering cangrelor at an amount between about 0.1 and about 4 μg/kg/min.
Cangrelor dose-rate between about 0.1 and about 0.5 μg/kg/min
Administering cangrelor at an amount between about 0.1 μg/kg/min and about 0.5 μg/kg/min.
Post-procedure administration between about 2 and about 4 hours
Administering the pharmaceutical composition between about 2 and about 4 hours after the procedure ends.
Overall, the claim coverage is directed to peri-procedural administration of cangrelor for pediatric congenital heart disease patients to treat shunt thrombosis and/or stent implantation, with the key inventive constraints centered on a defined post-procedure timing window and, in dependent claims, specific administration mode and dose-rate ranges.
Stated Advantages
Allows prevention and/or treatment of shunt thrombosis and stent thrombosis around the postoperative period before aspirin is typically administered.
Rapid, reversible platelet inhibition suitable for bridging compared with oral/irreversible thienopyridines.
Documented Applications
Preventing and/or treating shunt thrombosis after systemic-to-pulmonary artery shunt surgery in pediatric patients with congenital heart disease.
Preventing and/or treating stent thrombosis associated with stent implantation in pediatric patients with congenital heart disease.
Bridging from a peri-procedural period to oral antiplatelet therapy in pediatric congenital heart disease patients undergoing shunt surgery or stent implantation.
Use in neonates and pediatric patients with cyanotic congenital heart disease and single ventricle physiology undergoing shunt surgery or ductus arteriosus stent placement.
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