THE MEDICINES COMPANY ® ® N = 9000 SA/NSTEMI/STEMI Maintenance Plavix PCI PLATFORM Screening Cangrelor infusion Placebo infusion PlavixPlacebo Plavix PCI.

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Presentation transcript:

THE MEDICINES COMPANY ® ® N = 9000 SA/NSTEMI/STEMI Maintenance Plavix PCI PLATFORM Screening Cangrelor infusion Placebo infusion PlavixPlacebo Plavix PCI Placebo N = 6400 SA/NSTEMI No Plavix Cangrelor infusion Placebo infusion PlavixPlacebo Plavix PCI Placebo Randomization Treatment R R

THE MEDICINES COMPANY ® ® CHAMPION Program PCIPLATFORM Sites US, AU/NZ, W Europe, S Africa, WEU, EEU, India, South America US, AU/NZ, W Europe, EEU, India, South America, China Study population N = 9,000 N = 6,400 (increased from 4400) Requiring PCI +/- stent Stable AnginaStable Angina UA/NSTEMIUA/NSTEMI STEMISTEMI Stable AnginaStable Angina UA/NSTEMIUA/NSTEMI Comparator clopidogrel 600mg at start of PCI vs. cangrelor IV clopidogrel 600mg at end of PCI vs. cangrelor IV Effect Size 22.5%25%

THE MEDICINES COMPANY ® ® CHAMPION Patient Population INCLUSION CRITERIAINCLUSION CRITERIA – >18 yrs age – CAD pts indicated for angioplasty, with or without stent implantation ie. NSTEMI, UA, and stable angina (elective) with:  Positive troponin (NSTEMI)  UA with dynamic ECG changes and etiher diabetes or age >=65 – Informed consent EXCLUSION CRITERIAEXCLUSION CRITERIA – PCI: No recent (<5days) loading with clopidogrel (maintenance dose is allowed) – PLATFORM: Clopidogrel naïve (no clopidogrel < 7days prior to randomization)

THE MEDICINES COMPANY ® ® CHAMPION Program Endpoints Primary endpoints 48 hours  Composite incidence of death, MI and IDR Secondary endpoints 48 hours 30 days 1-year Death/MIDeath/MI Components of compositeComponents of composite Stroke (distinguished by type)Stroke (distinguished by type) Incidence of (threatened) abrupt closureIncidence of (threatened) abrupt closure Need for urgent CABGNeed for urgent CABG Unsuccessful procedure during the index PCIUnsuccessful procedure during the index PCI Death at 6 monthsDeath at 6 months Safety assessment Hemorrhage (e.g. ACUITY, GUSTO, TIMI criteria) Hemorrhage (e.g. ACUITY, GUSTO, TIMI criteria) Transfusions Transfusions SAE/AE through 48 hrs post-randomization. SAE/AE through 48 hrs post-randomization.

THE MEDICINES COMPANY ® ® Cangrelor Placebo Cangrelor Placebo Cangrelor Clopidogrel CHAMPION PLATFORM CHAMPION PCI P C I Placebo capsules Clopidogrel capsules Cangrelor IV P C I Clopidogrel capsules Placebo capsules Placebo IV P C I Placebo capsules Clopidogrel capsules Cangrelor IV P C I Clopidogrel capsules Placebo capsules Placebo IV Post - Infusion Post - PCI Pre - PCI Dosing Cangrelor: 30  g/kg bolus (i.v.) + 4  g/kg/min infusion for 2-4 hours not more than 30 mins before the guide wire crosses the lesion Double Blind/Double Dummy

THE MEDICINES COMPANY ® ® CHAMPION Countries USA Australia Spain France Poland Germany Netherlands Belgium India New Zealand Austria Czech Rep. Lithuania Ukraine Thailand South Africa Russia China (mainland) Georgia South Korea Bulgaria Turkey Brazil Slovakia Argentina Hungary