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)

Sergio Leonardi, Sunil V. Rao, Robert A. Harrington, Deepak L. Bhatt, C. Michael Gibson, Matthew T. Roe, Janusz Kochman, Kurt Huber, Uwe Zeymer, Mina Madan, Daniel D. Gretler, Matthew W. McClure, Gayle E. Paynter, Vivian Thompson, Robert C. Welsh

Research output: Contribution to journal › Article

Abstract

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.

Original languageEnglish
Pages (from-to)65-72
Number of pages8
JournalAmerican Heart Journal
Volume160
Issue number1
DOIs
Publication statusPublished - Jul 2010

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clopidogrel
Percutaneous Coronary Intervention
Intravenous Administration
Oral Administration
Platelet Aggregation Inhibitors
Blood Platelets
Aspirin
Emergencies
Hemorrhage
Safety
elinogrel

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / Leonardi, Sergio; Rao, Sunil V.; Harrington, Robert A.; Bhatt, Deepak L.; Gibson, C. Michael; Roe, Matthew T.; Kochman, Janusz; Huber, Kurt; Zeymer, Uwe; Madan, Mina; Gretler, Daniel D.; McClure, Matthew W.; Paynter, Gayle E.; Thompson, Vivian; Welsh, Robert C.

In: American Heart Journal, Vol. 160, No. 1, 07.2010, p. 65-72.

Research output: Contribution to journal › Article

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 2010, '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)', American Heart Journal, vol. 160, no. 1, pp. 65-72. https://doi.org/10.1016/j.ahj.2010.04.008
Leonardi S, Rao SV, Harrington RA, Bhatt DL, Gibson CM, Roe MT et al. 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). American Heart Journal. 2010 Jul;160(1):65-72. https://doi.org/10.1016/j.ahj.2010.04.008
Leonardi, Sergio ; Rao, Sunil V. ; Harrington, Robert A. ; Bhatt, Deepak L. ; Gibson, C. Michael ; Roe, Matthew T. ; Kochman, Janusz ; Huber, Kurt ; Zeymer, Uwe ; Madan, Mina ; Gretler, Daniel D. ; McClure, Matthew W. ; Paynter, Gayle E. ; Thompson, Vivian ; Welsh, Robert C. / 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). In: American Heart Journal. 2010 ; Vol. 160, No. 1. pp. 65-72.
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