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• 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