VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel

Phase 4 Completed 65 enrolled Andalusian Public Foundation for Health Research in Seville Andaluz Health Service · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

Timeline

Start: 2012-10
Primary completion: 2013-10
Completion: 2013-10

Outcome

Met primary endpoint

paper The non-high-platelet-reactivity rate (PRU < 208) at 24 h post-angioplasty (primary end point) was higher with prasugrel; PMID 26717223 ↗

paper 25 patients (100%) in the prasugrel group achieved optimal antiaggregation vs 4 patients (16%) in the clopidogrel group (P < 0.001). PMID 26717223 ↗

Publications

Cubero Gomez JM, Acosta Martinez J, Mendias Benitez C, Diaz De La Llera LS, Fernandez-Quero M, Guisado Rasco A, Villa Gil-Ortega M, Sanchez Gonzalez A. VERifyNow in DIabetes high-on-treatment platelet reactivity: a pharmacodynamic study on switching from clopidogrel to prasugrel. Acta Cardiol. 2015 Dec;70(6):728-34. doi: 10.2143/AC.70.6.3120187.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Clopidogrel	Small molecule	75 mg	—
Subject	Prasugrel	Small molecule	10 mg	—