Two additional concurrent clinical trials of the effect of KENGREAL in patients undergoing percutaneous coronary intervention, CHAMPION PCI and CHAMPION PLATFORM were conducted and terminated early for futility. They were completed prior to the design and conduct of CHAMPION PHOENIX. The comparative characteristics and outcomes of each trial are shown in Table 4.
|Subjects Randomized (% of planned enrollment)||8,846 (99%)||5,346 (84%)||11,145 (100%)|
|Primary Endpoint at 48 hours||Death, MI, or IDR||Death, MI, or IDR||Death, MI, IDR, or ST|
|Outcome of primary analysis, OR (95% CI)||1.05 (0.88, 1.24)||0.87 (0.71, 1.07)||0.78 (0.66, 0.93)|
|Clopidogrel dose and time in clopidogrel arm||600 mg immediately before PCI||600 mg immediately after PCI||300 or 600 mg shortly before or shortly after PCI|
|Population enrolled(%)||Stable angina||15%||5%||58%|
KENGREAL is supplied as a sterile lyophilized powder in single-use 10 mL vials.
- NDC # 10122-620-01: 10 mL vial containing 50 mg cangrelor
- NDC # 10122-620-10: 10 count of 10 mL vials containing 50 mg cangrelor
Vials of KENGREAL should be stored at USP Controlled Room Temperature, [20°C to 25°C (68°F to 77°F) with excursions between 15°C and 30°C (59°F and 86°F) permitted].
KENGREAL® is a registered trademeark of Chiesi Farmaceutici S.p.A.
Chiesi USA, Inc.
Cary, NC 27518
Principal Display Panel
( cangrelor ) for injection
50 mg per vial
Rx Only 10 Single Use Vials
|KENGREAL cangrelor injection, powder, lyophilized, for solution|
|Labeler — Chiesi USA, Inc. (088084228)|
|Registrant — Chiesi USA, Inc. (088084228)|
Revised: 09/2020 Chiesi USA, Inc.
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