Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel (ITALICplus)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial|
- composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- composite endpoint:Death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding and minor bleeding [ Time Frame: 36-month period ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
no clopidogrel 6 months after DES
Patients with a single treatment antiplatelet therapy (aspirin) 6 months after drug-eluting stent implantation (Xience V Abbott company), including a 12-, 24- and 36-month follow-up analysis.
2 antiplatelet therapy 2 years after DES
patients with dual antiplatelet therapy with clopidogrel and aspirin 24 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476020
|Contact: Martine Gilard, MD, PhD||+33 (0)2 98 34 75 email@example.com|
|Department of cardiology||Not yet recruiting|
|Brest, France, 29 609 Cedex|
|Contact: martine Gilard, MD, PhD +33 (0)2 98 34 75 05 firstname.lastname@example.org|
|Principal Investigator: Martine Gilard, MD, PhD|
|Principal Investigator:||martine Gilard, MD,PhD||Brest University France|