Restenosis Clinical Trial
Official title:
Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial
The ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials.
The use of drug-eluting stents has resulted in a significant reduction in the restenosis
rate and in the need for repeat angioplasty of the stented lesion. However, the occurrence
of late stent thrombosis has resulted in an increase in the duration of dual antiplatelet
treatment.
According to the guidelines of the ESC, the current recommended duration of dual
antiplatelet treatment is 12 months.
A relationship has been demonstrated between the occurrence of late stent thrombosis and
aspirin resistance.
Furthermore, dual anti-platelet treatment is associated with an increase in bleeding, the
severity of which has been well documented. In addition, the patients involved, and
especially those over 70, have significant co-morbidities often requiring extra-cardiac
surgery which cannot easily be carried out in patients on dual antiplatelet treatment or
clopidogrel.
The objective of this study is to determine whether, after a period of 6 months following
Drug eluting stent (DES) implantation in patients regarded as sensitive to aspirin, dual
antiplatelet therapy may be replaced by aspirin alone.
The original Italic Trial is a multicenter, randomized study evaluating the non-inferiority
of aspirin as a single treatment versus dual antiplatelet therapy with clopidogrel and
aspirin 6 months after drug-eluting stent implantation, including a 12-, 24- and 36-month
follow-up analysis.
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Observational Model: Cohort, Time Perspective: Prospective
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