KENGREAL® (cangrelor) Efficacy

Significant relative risk reduction in primary and secondary endpoints1,2

KENGREAL is specifically designed as an adjunct to PCI.1,2 See how it performed vs clopidogrel in the phase III pivotal trial, CHAMPION PHOENIX.

CHAMPION PHOENIX phase III trial results1

As an adjunct to PCI, KENGREAL significantly reduced the primary composite endpoint events of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours vs clopidogrel in an all-comer PCI patient population.

CHAMPION PHOENIX study design2

CHAMPION PHOENIX was a randomized, double-blind, placebo-controlled, phase III trial in 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy. Patients received a bolus and infusion of cangrelor or a loading dose of 600 mg or 300 mg of clopidogrel.

22% relative risk reduction in periprocedural thrombotic events1,2

CHAMPION PHOENIX primary composite endpoint (death/MI/IDR/stent thrombosis at 48 hours): KENGREAL vs clopidogrel in an all-comer PCI patient population

Stent thrombosis at 48 hours1,2

*mITT population

Breakdown by individual endpoints: Outcomes at 48 hours, mITT*1

mITT= modified intention-to-treat.

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.

Breakdown of primary composite endpoint according to patient subgroups at 48 hours, mITT population1

Note: The figure presents effects in various subgroups, most of which are baseline characteristics and most of which were prespecified (patient presentation and weight were not prespecified subgroups). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be overinterpreted.

Supplementary FDA-requested endpoint:
Outcomes at 48 hours, mITT1

This analysis omitted 2 subcomponent events from the primary endpoint of lesser clinical significance:

  • Intraprocedural stent thrombosis (defined as a new or increasing thrombus within or adjacent to a deployed stent occurring during the index PCI procedure)
  • MI with <10-fold increase in CK-MB, or with <5-fold increase in CK-MB in the presence of new Q waves or new left bundle branch block (LBBB)

*SCAI MI: CK-MB ≥10X ULN, or CK-MB ≥5X ULN with new Q waves or new LBBB.

†ARC-ST defined according to the ARC definition.

ARC=Academic Research Consortium; CK-MB=creatine kinase MB isoenzyme; MI=myocardial infarction;
SCAI=Society for Cardiovascular Angiography and Interventions; ST=stent thombosis.

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

Read patient profiles to determine if KENGREAL® (cangrelor) may be appropriate

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KENGREAL dosing chart

Find the dose of KENGREAL needed for your patients

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KENGREAL onset and offset time

KENGREAL offers rapid platelet inhibition with quick offset1

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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.

INDICATION

KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

References: 1. KENGREAL® (cangrelor) Prescribing Information. 2016. 2. Bhatt DL, Stone GW, Mahaffey KW, et al; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013;368(14):1303-1313. 3. Data on file. Chiesi USA, Inc.