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CHAMPION PHOENIX*

Pivotal phase 3 trial1

  • Purpose: PHOENIX tested whether faster platelet inhibition with cangrelor at the time of PCI would reduce periprocedural thrombotic events compared to a drug with a slower antiplatelet effect, clopidogrel, given at the time of PCI
  • Design: Randomized (1:1), double-blind, double-dummy trial
  • Comparator: clopidogrel (300 or 600 mg) according to standard of care
  • Key inclusion criteria:
    • - SA/NSTE-ACS: Confirmed need for PCI (by angiography)
    • - STEMI: Intent for emergent PCI
  • Key exclusion criteria:
    • - Pretreated with an oral P2Y12 inhibitor in the past 7 days
    • - Planned GP IIb/IIIa inhibitor use

Study design1

Study design of CHAMPION PHOENIX clinical trials

*P2Y12 inhibitor naïve.

18.8% of patients overall received bivalirudin during PCI, 92% of bivalirudin use was in the US.

Administration (dose and timing) of loading dose of clopidogrel was at the operator’s discretion. Overall, 76% received 600 mg clopidogrel; in the US, 99% of patients received 600 mg clopidogrel.

SA=stable angina; NSTE-ACS=non-ST segment elevation acute coronary syndromes; STEMI=ST segment elevation myocardial infarction; mITT=modified intent-to-treat; RAND=randomization.

Efficacy endpoints, 48 hours

PRESPECIFIED primary efficacy composite endpoint1:

Death/MI/IDR/ST

  • Myocardial infarction (UDMI) definition:
    • - CK-MB ≥3x ULN if baseline normal
    • - CK-MB >50% increase if baseline abnormal + objective evidence of ischemia
  • Ischemia-driven revascularization (IDR)
  • Stent thrombosis (ST): Academic Research Consortium (ARC) ST + Intraprocedural ST (IPST)

SUPPLEMENTARY primary efficacy composite endpoint1:

Death/SCAI MI/IDR/ARC ST

  • Myocardial infarction (SCAI) definition:
    • - CK-MB ≥10x ULN if baseline normal, or
    • - CK-MB >5x ULN with new Q waves or new LBBB
  • Ischemia-driven revascularization (IDR)
  • Stent thrombosis (ST): Academic Research Consortium (ARC) ST

The KENGREAL® clinical development program included approximately 25,000 patients. In addition to CHAMPION PHOENIX, there were two additional concurrent clinical trials of the effect of KENGREAL® in patients undergoing percutaneous coronary intervention, CHAMPION PCI and CHAMPION PLATFORM, which were conducted and terminated early for futility

Primary efficacy outcomes at 48 hours, mITT§1,2

Cangrelor
(N=5472)
Clopidogrel
(N=5470)
OR (95% CI) P-value
Primary outcome,
adjusted
Death/MI/IDR/ST 257/5470 (4.7%) 322/5469 (5.9%) 0.78 (0.66, 0.93)|| 0.005
Secondary efficacy outcomes at 48 hours, mITT
Death 18/5470 (0.3) 18/5469 (0.3)
MI 202/5470 (3.7) 254/5469 (4.6)
IDR 10/5470 (0.2) 14/5469 (0.3)
Stent thrombosis (ST) 27/5470 (0.5%) 36/5469 (0.7%)

Note: if a subject had more than one event at 48 hours, then worst outcome counted (death >MI >IDR >ST).

§The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.

||Based on logistic model adjusted for loading dose and baseline patient status for primary endpoint.

References: 1. KENGREAL® (cangrelor) Prescribing Information. 2016. 2. Bhatt DL, et al. N Engl J Med. 2013;368:1303-13.

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.

Please see full prescribing information.

www.kengreal.com

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