THE THE MEDICINESMEDICINES COMPANY COMPANY®®®®
• N = 9000• SA/NSTEMI/STEMI• Maintenance Plavix
PCI
PLATFORM
Screening
Cangrelor infusion
Placebo infusion
Plavix Placebo
Plavix
PCI
Placebo
• N = 6400• SA/NSTEMI• No Plavix
Cangrelor infusion
Placebo infusion
Plavix Placebo
Plavix
PCI
Placebo
Randomization Treatment
R
R
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CHAMPION ProgramCHAMPION Program
PCIPCI PLATFORMPLATFORM
SitesSites US, AU/NZ, W Europe, S Africa, US, AU/NZ, W Europe, S Africa, WEU, EEU, India, South AmericaWEU, EEU, India, South America
US, AU/NZ, W Europe, EEU, India, US, AU/NZ, W Europe, EEU, India, South America, ChinaSouth America, China
Study Study populationpopulation
N = 9,000N = 9,000 N = 6,400N = 6,400 (increased from 4400) (increased from 4400)
Requiring PCI +/- stentRequiring PCI +/- stent
•Stable AnginaStable Angina
•UA/NSTEMIUA/NSTEMI
•STEMISTEMI
•Stable AnginaStable Angina
•UA/NSTEMIUA/NSTEMI
ComparatorComparator clopidogrel clopidogrel 600mg at 600mg at start of PCIstart of PCI
vsvs.. cangrelor cangrelor IV IV
clopidogrel clopidogrel 600mg at 600mg at end of PCI end of PCI
vsvs.. cangrelor cangrelor IV IV
Effect SizeEffect Size 22.5%22.5% 25%25%
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CHAMPION Patient PopulationCHAMPION Patient Population
• INCLUSION CRITERIAINCLUSION CRITERIA
– >18 yrs age>18 yrs age
– CAD pts indicated for angioplasty, with or without stent implantation ie. CAD pts indicated for angioplasty, with or without stent implantation ie. NSTEMI, UA, and stable angina (elective) with:NSTEMI, UA, and stable angina (elective) with:
Positive troponin (NSTEMI)Positive troponin (NSTEMI)
UA with dynamic ECG changes and etiher diabetes or age >=65UA with dynamic ECG changes and etiher diabetes or age >=65
– Informed consentInformed consent
• EXCLUSION CRITERIAEXCLUSION CRITERIA
– PCI:PCI: No recent (<5days) loading with clopidogrel ( No recent (<5days) loading with clopidogrel (maintenance dosemaintenance dose is is allowedallowed))
– PLATFORM:PLATFORM: Clopidogrel naïve (no clopidogrel < 7days prior to Clopidogrel naïve (no clopidogrel < 7days prior to randomization)randomization)
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CHAMPION Program EndpointsCHAMPION Program Endpoints
Primary Primary endpointsendpoints 48 hours48 hours Composite incidence of death, MI and IDRComposite incidence of death, MI and IDR
Secondary Secondary endpointsendpoints
48 hours48 hours
30 days30 days
1-year1-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 Safety assessmentassessment
• Hemorrhage (e.g. ACUITY, GUSTO, TIMI criteria)Hemorrhage (e.g. ACUITY, GUSTO, TIMI criteria)
• TransfusionsTransfusions
• SAE/AE through 48 hrs post-randomization.SAE/AE through 48 hrs post-randomization.
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Cangrelor PlaceboCangrelor PlaceboCangrelor ClopidogrelCangrelor Clopidogrel
CHAMPION PLATFORMCHAMPION PLATFORMCHAMPION PCICHAMPION PCI
P C I
Placebo capsules
Clopidogrel capsules
Cangrelor IV
P C I
Clopidogrelcapsules
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
DosingDosing
Cangrelor: Cangrelor: 30 30 g/kg bolus (i.v.)g/kg bolus (i.v.) + + 44g/kg/min infusiong/kg/min infusion for 2-4 hours for 2-4 hours
•not more than 30 mins before the guide wire crosses the lesion
•Double Blind/Double Dummy
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CHAMPION CountriesCHAMPION Countries
USA
Australia
Spain
France
Poland
Germany
NetherlandsBelgium
India
New Zealand
Austria
Czech Rep.Lithuania
Ukraine
Thailand
South Africa
Russia
China(mainland)
Georgia
South KoreaBulgaria Turkey
Brazil
Slovakia
Argentina
Hungary