title: 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).
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 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.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. sergio.leonardi@duke.edu
authors.forename: Sergio
authors.initials: S
authors.lastname: Leonardi
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.forename: Janusz
authors.initials: J
authors.lastname: Kochman
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Mina
authors.initials: M
authors.lastname: Madan
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Gretler
authors.forename: Matthew W
authors.initials: MW
authors.lastname: McClure
authors.forename: Gayle E
authors.initials: GE
authors.lastname: Paynter
authors.forename: Vivian
authors.initials: V
authors.lastname: Thompson
authors.forename: Robert C
authors.initials: RC
authors.lastname: Welsh
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000378:metabolism / Q000628:therapy*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics; D058919:Purinergic P2 Receptor Antagonists; D052999:Quinazolinones / Q000008:administration & dosage* / Q000493:pharmacokinetics; D058925:Receptors, Purinergic P2Y12; D013449:Sulfonamides / Q000008:administration & dosage* / Q000493:pharmacokinetics; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013997:Time Factors; D016896:Treatment Outcome; D014336:Troponin / Q000097:blood; D055815:Young Adult
chemical_list: C548576:P2RY12 protein, human; D010975:Platelet Aggregation Inhibitors; D058919:Purinergic P2 Receptor Antagonists; D052999:Quinazolinones; D058925:Receptors, Purinergic P2Y12; D013449:Sulfonamides; D014336:Troponin; C549473:elinogrel; D000077144:Clopidogrel; D013988:Ticlopidine