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Claims for Patent: 8,680,052

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Claims for Patent: 8,680,052

Title:Methods of treating, reducing the incidence of, and/or preventing ischemic events
Abstract: Methods of treating, reducing the incidence of, and/or preventing an ischemic event in a patient undergoing percutaneous coronary intervention (PCI), comprising administering to the patient a pharmaceutical composition comprising cangrelor. The method may further comprise administering an additional therapeutic agent to the patient, the additional therapeutic agent comprising a P2Y.sub.12 inhibitor. Pharmaceutical compositions useful for treating, reducing the incidence of, and/or preventing an ischemic event in a patient undergoing PCI. The pharmaceutical compositions comprise cangrelor. Methods of preparing a pharmaceutical composition for treating, reducing the incidence of, and/or preventing an ischemic event in a patient undergoing PCI, comprising admixing cangrelor with one or more pharmaceutically acceptable excipients. An ischemic event may include stent thrombosis, myocardial infarction, ischemia-driven revascularization, and mortality.
Inventor(s): Arculus-Meanwell; Clive Arthur (Bernardsville, NJ), Skerjanec; Simona (Basel, CH), Prats; Jayne (Carlisle, MA), Schneider; David J. (Colchester, VT)
Assignee: The Medicines Company (Parsippany, NJ)
Application Number:13/904,778
Patent Claims: 1. A method of transitioning a patient from administration of cangrelor during percutaneous coronary intervention (PCI) to administration of ticagrelor for chronic treatment, the method comprising: (1) administering intravenously a 30 .mu.g/kg bolus of cangrelor before the start of PCI; (2) administering intravenously a 4 .mu.g/kg/min continuous infusion of cangrelor after administration of the bolus; (3) continuing the administration of the continuous infusion for the longer of (a) at least two hours, or (b) the duration of PCI; and (4) administering an oral dose of ticagrelor either (a) during administration of the continuous infusion, or (b) after discontinuation of the administration of the continuous infusion, wherein the oral dose comprises a 180 mg loading dose of ticagrelor.

2. The method of claim 1, wherein the patient received oral P2Y.sub.12 therapy prior to the administration of cangrelor without attenuation of the effect of cangrelor.

3. The method of claim 2, wherein the oral P2Y.sub.12 therapy is selected from the group consisting of clopidogrel, prasugrel, and ticagrelor.

4. The method of claim 1, wherein cangrelor is in a pharmaceutical composition comprising 200 .mu.g/mL of cangrelor.

5. The method of claim 4, wherein the pharmaceutical composition further comprises sodium chloride injection 0.9% or 5% dextrose injection.

6. The method of claim 1, wherein the bolus is administered in less than one minute.

7. The method of claim 1, wherein the continuous infusion is continued for a total duration of up to about four hours.

8. The method of claim 1, wherein the method further comprises administering one or more oral doses of ticagrelor subsequent to the loading dose.

9. The method of claim 8, wherein the one or more subsequent oral doses comprise 90 mg of ticagrelor.

10. The method of claim 1, wherein the administration of the continuous infusion is started immediately after the administration of the bolus.

11. The method of claim 1, wherein the method further comprises administering aspirin before or during administration of the continuous infusion.

12. A method of transitioning a patient from administration of cangrelor during percutaneous coronary intervention (PCI) to administration of ticagrelor for chronic treatment, the method comprising: (1) administering intravenously a 30 .mu.g/kg bolus of cangrelor before the start of PCI; (2) administering intravenously a 4 .mu.g/kg/min continuous infusion of cangrelor after administration of the bolus; (3) continuing the administration of the continuous infusion of cangrelor for the longer of (a) at least two hours, or (b) the duration of PCI; and (4) administering an oral dose of ticagrelor during administration of the continuous infusion, wherein the oral dose comprises a 180 mg loading dose of ticagrelor.

13. The method of claim 12, wherein the patient received oral P2Y.sub.12 therapy prior to the administration of cangrelor without attenuation of the effect of cangrelor.

14. The method of claim 13, wherein the oral P2Y.sub.12 therapy is selected from the group consisting of clopidogrel, prasugrel, and ticagrelor.

15. The method of claim 12, wherein cangrelor is in a pharmaceutical composition comprising 200 .mu.g/mL of cangrelor.

16. The method of claim 15, wherein the pharmaceutical composition further comprises sodium chloride injection 0.9% or 5% dextrose injection.

17. The method of claim 12, wherein the bolus is administered in less than one minute.

18. The method of claim 12, wherein the continuous infusion is continued for a total duration of up to about 4 hours.

19. The method of claim 12, wherein the method further comprises administering one or more oral doses of ticagrelor subsequent to the loading dose.

20. The method of claim 19, wherein the one or more subsequent oral doses comprise 90 mg of ticagrelor.

21. The method of claim 19, wherein the one or more subsequent oral doses continue after discontinuation of the administration of the continuous infusion.

22. A method of transitioning a patient from administration of cangrelor during percutaneous coronary intervention (PCI) to administration of ticagrelor for chronic treatment, the method comprising: (1) administering intravenously a 30 .mu.g/kg bolus of cangrelor before the start of PCI; (2) administering intravenously a 4 .mu.g/kg/min continuous infusion of cangrelor after administration of the bolus; (3) continuing the administration of the continuous infusion for the longer of (a) at least two hours, or (b) the duration of PCI; and (4) administering an oral dose of ticagrelor after discontinuation of the administration of the continuous infusion, wherein the oral dose comprises a 180 mg loading dose of ticagrelor.

23. The method of claim 22, wherein the patient received oral P2Y.sub.12 therapy prior to the administration of cangrelor without attenuation of the effect of cangrelor.

24. The method of claim 23, wherein the oral P2Y.sub.12 therapy is selected from the group consisting of clopidogrel, prasugrel, and ticagrelor.

25. The method of claim 22, wherein cangrelor is in a pharmaceutical composition comprising 200 .mu.g/mL of cangrelor.

26. The method of claim 25, wherein the pharmaceutical composition further comprises sodium chloride injection 0.9% or 5% dextrose injection.

27. The method of claim 22, wherein the bolus is administered in less than one minute.

28. The method of claim 22, wherein the continuous infusion is continued for a total duration of up to about 4 hours.

29. The method of claim 22, wherein the method further comprises administering one or more oral doses of ticagrelor subsequent to the loading dose.

30. The method of claim 29, wherein the one or more subsequent oral doses comprise 90 mg of ticagrelor.
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