TY - JOUR
T1 - Rationale and design of the randomized, double-blind trial testing INtraveNous and Oral administration of elinogrel, a selective and reversible P2Y12-receptor inhibitor, versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients (INNOVATE-PCI)
AU - Leonardi, Sergio
AU - Rao, Sunil V.
AU - Harrington, Robert A.
AU - Bhatt, Deepak L.
AU - Gibson, C. Michael
AU - Roe, Matthew T.
AU - Kochman, Janusz
AU - Huber, Kurt
AU - Zeymer, Uwe
AU - Madan, Mina
AU - Gretler, Daniel D.
AU - McClure, Matthew W.
AU - Paynter, Gayle E.
AU - Thompson, Vivian
AU - Welsh, Robert C.
PY - 2010/7
Y1 - 2010/7
N2 - Despite current dual-antiplatelet therapy with aspirin and clopidogrel, adverse clinical events continue to occur during and after percutaneous coronary intervention (PCI). The failure of clopidogrel to provide optimal protection may be related to delayed onset of action, interpatient variability in its effect, and an insufficient level of platelet inhibition. Furthermore, the irreversible binding of clopidogrel to the P2Y12 receptor for the life span of the platelet is associated with increased bleeding risk especially during urgent or emergency surgery. Novel antiplatelet agents are required to improve management of patients undergoing PCI. Elinogrel is a potent, direct-acting (ie, non-prodrug), selective, competitive, and reversible P2Y 12 inhibitor available in both intravenous and oral formulations. The INNOVATE-PCI study is a phase 2 randomized, double-blind, clopidogrel- controlled trial to evaluate the safety, tolerability, and preliminary efficacy of this novel antiplatelet agent in patients undergoing nonurgent PCI.
AB - Despite current dual-antiplatelet therapy with aspirin and clopidogrel, adverse clinical events continue to occur during and after percutaneous coronary intervention (PCI). The failure of clopidogrel to provide optimal protection may be related to delayed onset of action, interpatient variability in its effect, and an insufficient level of platelet inhibition. Furthermore, the irreversible binding of clopidogrel to the P2Y12 receptor for the life span of the platelet is associated with increased bleeding risk especially during urgent or emergency surgery. Novel antiplatelet agents are required to improve management of patients undergoing PCI. Elinogrel is a potent, direct-acting (ie, non-prodrug), selective, competitive, and reversible P2Y 12 inhibitor available in both intravenous and oral formulations. The INNOVATE-PCI study is a phase 2 randomized, double-blind, clopidogrel- controlled trial to evaluate the safety, tolerability, and preliminary efficacy of this novel antiplatelet agent in patients undergoing nonurgent PCI.
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U2 - 10.1016/j.ahj.2010.04.008
DO - 10.1016/j.ahj.2010.04.008
M3 - Article
C2 - 20598974
AN - SCOPUS:77955677366
VL - 160
SP - 65
EP - 72
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 1
ER -