Restenosis Clinical Trial
Official title:
The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study
Background
Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need
for repeat revascularization procedures in patients who undergo PCI. The potential increased
incidence of late stent thrombosis prompted cardiologists to prolong the use of dual
anti-platelet therapy after the one year duration recommended by the recent ESC guidelines.
However, while the premise that the cardiologists should put all their patients on dual
clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because
of the potential increase of bleeding complications and of the healthcare cost increase. The
recent possibility to monitor aspirin with bedside assays offers a real opportunity to
compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen
versus mono-aspirin regimen and to respond to the key question: can the investigators switch
from dual to single antiplatelet therapy after six months in good aspirin responder patients
? Study National, multicenter, randomised prospective open group comparison of dual
clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients
treated with DES (name: XIENCE) implantation.
End point Primary: At 12 months: death, myocardial infarction, repeat urgent
revascularization, stroke requiring a new hospitalisation and major bleedings.
Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE)
implantation, of the same composite endpoint and incidence at 12, 24 and 36 months of minor
bleeding complications Participating centres: 60 french centers
Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45
months
n/a
Time Perspective: Prospective
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