In:
Drug Development Research, Wiley, Vol. 74, No. 8 ( 2013-12), p. 526-532
Abstract:
Clinical Development Phases I‐III Regulatory, Quality, Manufacturing The antagonism of the platelet P2Y 12 receptor is essential for the treatment of patients undergoing percutaneous coronary intervention ( PCI ). Cangrelor is an intravenous P2Y 12 receptor antagonist that being both reversible and very short acting has the potential to overcome some of the limitations of currently available oral agents like clopidogrel, prasugrel, and ticagrelor. Cangrelor has been studied in a large phase III program called Cangrelor versus standard therapy to acHieve optimal M anagement of P latelet InhibitiON ( CHAMPION ) that included three randomized controlled trials ( RCT s): PCI , P LATFORM , and PHOENIX . The first two RCT s, conducted concurrently, were prematurely interrupted for futility. However, it was soon evident that unanticipated challenges in the ascertainment of PCI ‐related myocardial infarction ( MI ) due to shorter‐than‐expected times to cardiac catheterization may have reduced the ability to detect cangrelor efficacy. While CHAMPION PCI and PLATFORM were ongoing, the universal definition of MI provided recommendations to address these challenges. Specifically, this consensus document recommended the presence of a rise and/or a fall of cardiac biomarkers to define MI . The universal MI definition enhanced by novel approaches to efficiently and accurately implement this definition was used to adjudicate MI in PHOENIX , which showed superiority of cangrelor over clopidogrel, with an effect that was mostly evident in MI . The development of cangrelor illustrates the critical importance of PCI ‐related MI as end point, the challenges in its definition in patients undergoing a very early invasive management, and the role of the universal MI definition in overcoming these challenges.
Type of Medium:
Online Resource
ISSN:
0272-4391
,
1098-2299
DOI:
10.1002/ddr.2013.74.issue-8
Language:
English
Publisher:
Wiley
Publication Date:
2013
detail.hit.zdb_id:
1500191-X
SSG:
15,3
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