The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel (ITALIC)
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
|Study Design:||Time Perspective: Prospective|
|Official Title:||The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study|
- Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780156
|Brest, France, 29200|