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).
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.
Leonardi
Sergio
S
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. sergio.leonardi@duke.edu
Rao
Sunil V
SV
Harrington
Robert A
RA
Bhatt
Deepak L
DL
Gibson
C Michael
CM
Roe
Matthew T
MT
Kochman
Janusz
J
Huber
Kurt
K
Zeymer
Uwe
U
Madan
Mina
M
Gretler
Daniel D
DD
McClure
Matthew W
MW
Paynter
Gayle E
GE
Thompson
Vivian
V
Welsh
Robert C
RC
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
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