title: Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial.
abstract: BACKGROUND
  Despite robust efficacy in the reduction of ischemic events in patients who require percutaneous coronary intervention (PCI), current P2Y(12) inhibitors have limitations. In particular, they require hours to be effective, and they can only be administered orally. Cangrelor is an intravenous, potent, and reversible P2Y(12) inhibitor with fast onset and offset of action. We designed CHAMPION PHOENIX to evaluate the efficacy and safety of cangrelor in patients with atherosclerosis undergoing PCI.
  
  
  METHODS
  The CHAMPION PHOENIX is a randomized, double-blind, double-dummy, superiority trial comparing cangrelor with clopidogrel standard of care in approximately 10,900 patients who have not previously received a P2Y(12) inhibitor and who require PCI, including patients with stable angina and with acute coronary syndromes (with or without ST-segment elevation). The primary objective of the study is to demonstrate that cangrelor will reduce the incidence of the composite of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis in the 48 hours after randomization compared with clopidogrel without excessive periprocedural bleeding. The key secondary objective is to demonstrate that cangrelor will reduce the incidence of stent thrombosis. Myocardial infarction will be defined according to the universal MI definition, adapting the definition of PCI-related (type 4a) MI. Bleeding will be assessed according to the thrombolysis in myocardial infarction, GUSTO, and Bleeding Academic Research Consortium (BARC) scales.
  
  
  CONCLUSIONS
  The CHAMPION PHOENIX may establish the role of cangrelor in the care of patients who require PCI across the spectrum of stable and unstable coronary diseases in the setting of current treatment strategies.
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Sergio
authors.initials: S
authors.lastname: Leonardi
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Gabriel W
authors.initials: GW
authors.lastname: Steg
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.forename: Meredith
authors.initials: M
authors.lastname: Todd
authors.forename: Markus
authors.initials: M
authors.lastname: Dietrich
authors.forename: Dianne
authors.initials: D
authors.lastname: Gallup
authors.forename: Tiepu
authors.initials: T
authors.lastname: Liu
authors.forename: Simona
authors.initials: S
authors.lastname: Skerjanec
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000249:Adenosine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D000077144:Clopidogrel; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage; D018570:Risk Assessment; D016019:Survival Analysis; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000249:Adenosine Monophosphate; C117446:cangrelor; D000077144:Clopidogrel; D013988:Ticlopidine