Rationale and design of the randomized, double-blind trial testing INtraveNous and Oral administration of elinogrel, a selective and reversible P2Y(12)-receptor inhibitor, versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients (INNOVATE-PCI).

Published

Journal Article

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 P2Y(12) 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.

Full Text

Duke Authors

Cited Authors

  • Leonardi, S; Rao, SV; Harrington, RA; Bhatt, DL; Gibson, CM; Roe, MT; Kochman, J; Huber, K; Zeymer, U; Madan, M; Gretler, DD; McClure, MW; Paynter, GE; Thompson, V; Welsh, RC

Published Date

  • July 2010

Published In

Volume / Issue

  • 160 / 1

Start / End Page

  • 65 - 72

PubMed ID

  • 20598974

Pubmed Central ID

  • 20598974

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2010.04.008

Language

  • eng

Conference Location

  • United States