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; Thompson, Vivian; Welsh, Robert C.

doi:10.1016/j.ahj.2010.04.008

Cited by 69 publications

(44 citation statements)

References 29 publications

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“…8,9 Recently, the dose-ranging Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability and Efficacy in Nonurgent PCI Patients (INNOVATE-PCI) phase 2b trial conducted in patients undergoing nonurgent PCI showed that elinogrel was not associated with increased major or minor bleeding, defined by Thrombolysis In Myocardial Infarction criteria, although there was an increase in bleeding requiring medical attention, primarily at the PCI access site. 10,11 The present article reports the results of the predefined PK and PD substudy of the INNOVATE-PCI trial.…”

Section: Editorial See P 328mentioning

confidence: 99%

“…Details of the INNOVATE-PCI trial are described elsewhere. 10,11 In brief, the INNOVATE-PCI trial (NCT00751231) was a multicenter, phase 2b, randomized, double-blind, triple-dummy, active-controlled study of IV and oral elinogrel compared with clopidogrel in patients undergoing nonurgent PCI conducted at 60 sites in Canada, Europe, and the United States. Patients scheduled to undergo nonurgent PCI fulfilling study inclusion and exclusion criteria were eligible for randomization.…”

Section: Patient Population and Study Designmentioning

confidence: 99%

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Pharmacokinetic and Pharmacodynamic Effects of Elinogrel

Angiolillo

Welsh

Trenk

et al. 2012

Circ: Cardiovascular Interventions

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Background-Elinogrel is the only selective, competitive and reversible platelet P2Y 12 inhibitor available in both intravenous (IV) and oral formulations. Methods and Results-This substudy of the Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability andEfficacy in Nonurgent Percutaneous Coronary Intervention patients (INNOVATE-PCI) trial evaluated the pharmacokinetic and pharmacodynamic effects of two dosing regimens of IV followed by oral elinogrel (120 mg IV plus 100 mg oral twice daily; 120 mg IV plus 150 mg oral twice daily) versus standard clopidogrel therapy (300 -600 mg oral loading dose plus 75 mg oral maintenance dose) in 56 patients undergoing nonurgent PCI. At time of randomization, 71.4% (40/56) of patients were using maintenance clopidogrel therapy. In the acute phase, an IV bolus of elinogrel achieved more rapid and potent antiplatelet effects compared with clopidogrel, which were sustained during the transition from the IV to the oral formulation in the first 24 hours of the peri-PCI period. During chronic therapy, elinogrel achieved similar levels of platelet reactivity compared with clopidogrel before the next oral dose and, although platelet reactivity was lower with elinogrel up to 6 hours after daily oral maintenance dosing, these differences were not statistically significant. These pharmacodynamic effects matched the pharmacokinetic profile of elinogrel. There were no differences in pharmacodynamic and pharmacokinetic effects between the two elinogrel dosing regimens. Conclusions-Compared with clopidogrel, the combination of IV and oral elinogrel achieves more rapid and enhanced antiplatelet effects that were sustained through the transition to oral elinogrel in the peri-PCI period, but these were not significant during chronic dosing in this pilot investigation. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751231.

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Section: Editorial See P 328mentioning

confidence: 99%

Section: Patient Population and Study Designmentioning

confidence: 99%

Pharmacokinetic and Pharmacodynamic Effects of Elinogrel

Angiolillo

Welsh

Trenk

et al. 2012

Circ: Cardiovascular Interventions

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“…57 No differences were observed in the rate of the primary safety end point (INNOVATE-PCI) study, 652 patients scheduled for nonurgent PCI were randomized to clopidogrel (300 to 600 mg load followed by 75 mg daily thereafter) or to elinogrel (80 mg IV bolus followed by oral dosing of 50, 100, or 150 mg bid thereafter). 52 The Data Safety Monitoring Board recommended discontinuation of the 50-mg oral dose and suggested increasing the IV dose to 120 mg. The study was not powered for effi cacy, but patients given elinogrel exhibited greater platelet inhibition than those treated with clopidogrel.…”

Section: Elinogrelmentioning

confidence: 99%

“…Abnormal liver function tests also were more common with elinogrel, but the abnormalities appeared to resolve over time, even if the drug was continued. 51,52 Elinogrel will soon undergo phase 3 evaluation in aspirin-treated patients with a history of MI within the past 6 months to 5 years. Such patients will be randomized to elinogrel (in one of two doses) or to placebo for approximately 29 months.…”

Section: Elinogrelmentioning

confidence: 99%

New Antithrombotic Drugs

Weitz

Eikelboom

Samama

2012

Chest

279

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“…The safety and degree of platelet inhibition of elinogrel on top of aspirin in patients scheduled for non-urgent PCI was assessed in the Phase II INNOVATE-PCI trial, which randomised 652 patients to four treatment arms: a control group receiving clopidogrel 300 --600 mg followed by 75 mg/day, and three groups randomised to an 80 mg intravenous bolus of elinogrel followed by a 50, 100 or 150 mg oral dose twice daily [81]. The results showed that, although elinogrel induced greater platelet inhibition than the standard doses of clopidogrel, there was no increase in TIMI major or minor bleeding in the periprocedural period or in the 120 days of follow-up.…”

Section: Elinogrelmentioning

confidence: 99%