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)

• Published in: The American heart journal 2010-07, Vol.160 (1), p.65-72
• Main Authors: Leonardi, Sergio, MD, Rao, Sunil V., MD, Harrington, Robert A., MD, Bhatt, Deepak L., MD, MPH, Gibson, C. Michael, MS, MD, Roe, Matthew T., MD, Kochman, Janusz, MD, PhD, Huber, Kurt, MD, Zeymer, Uwe, MD, Madan, Mina, MD, MHS, Gretler, Daniel D., MD, McClure, Matthew W., MD, Paynter, Gayle E., RN, BS, Thompson, Vivian, MPH, Welsh, Robert C., MD
• Format: Article
• Language: English
• Subjects: Acute coronary syndromes; Biological and medical sciences; Blood platelets; Cardiology. Vascular system; Cardiovascular; Coronary vessels; Diseases of the cardiovascular system; Drug dosages; Drug therapy; Heart attacks; Ischemia; Medical imaging; Medical sciences; Mortality; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stroke; Surgery; Thrombosis
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2010.04.008

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 P2Y12 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.