KENGREAL® (cangrelor) Safety
Clinical bleeding results1
Bleeding events were studied in the CHAMPION PHOENIX study
- In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL than with clopidogrel1
- Patients receiving KENGREAL had no statistically significant increase in either GUSTO-defined severe bleeding or need for transfusion2
CHAMPION PHOENIX study design2
CHAMPION PHOENIX was a randomized, double-blind, placebo-controlled, phase III trial in 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy. Patients received a bolus and infusion of cangrelor or a loading dose of 600 mg or 300 mg of clopidogrel.
Clinical bleeding results1
*Safety population is randomized subjects who received at least one dose of study drug.
†lntracranial hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment.
‡Requiring blood transfusion but not resulting in hemodynamic compromise.
§All other bleeding not included in severe or moderate.
‖Any intracranial hemorrhage, or any overt bleeding associated with a reduction in hemoglobin of ≥5 g/dL (or when hemoglobin is not available, an absolute reduction in hematocrit ≥15%).
¶Any overt sign of bleeding (including observation by imaging techniques) that is associated with a reduction in hemoglobin of ≥3 g/dL and <5 g/dL (or, when hemoglobin is not available, an absolute reduction in hematocrit of ≥9% and <15%).
GUSTO=GIobal Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries;
TIMI=Thrombolysis in Myocardial Infarction.
Bleeding risk in subgroup populations1
In the study, no baseline demographic factors altered the relative risk of bleeding with KENGREAL. Patient subgroups were divided by age, sex, race, weight, ACS status, prior TIA/stroke, and diabetes. Bleeding events with KENGREAL were similar across patient subgroups.
Any bleeding at 48 hours (non–CABG-related), safety population*1
*Safety population is all randomized subjects who received at least one dose of study drug.
Note: The figure presents effects in various subgroups, most of which are baseline characteristics and most of which were prespecified (patient presentation and weight were not prespecified subgroups). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be overinterpreted.
IMPORTANT SAFETY INFORMATION
KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding.
KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.