Clinical trial NCT01476020: Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel
Official title: Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Restenosis
Keywords: Drug eluting stent
Dual antiplatelet therapy
bleeding
stent thrombosis
follow-up of the drug eluting stent
Lead sponsor: Gilard, Martine
Sponsor class: INDIV
Collaborators: name: Clinical Research Organization and study management
name: Abbott Medical Devices
First posted: 2011-11-22
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are selected from the general population needing Percutaneous Coronary Interventions (PCI).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female subject ≥ 18 years of age eligible for PCI with at least one drug eluting stent (name: Xience) implanted in all clinical situations excluding primary PCI for acute MI and treatment of the left main artery.
* Male or female subject ≥ 18 years of age eligible for PCI with at least one DES Xience.
* Patient not pre-treated with protein IIb/IIIa inhibitors (name: abxicimab or eptifibatide) during hospitalization
* Patient pre-treated with aspirin and clopidogrel before PCI
* ASA check at least 24 hours after the interruption of tirofiban
* The subject has given written informed and dated consent to participate in this study.

Exclusion Criteria:

* Subjects not able to give informed consent
* Prior implantation of DES
* Known platelets \< 100 000/µl or known hemorrhagic diathesis
* Oral anticoagulation or treatment with abxicimab or eptifibatide during hospitalization
* ASA check less than 24 hours after the interruption of tirofiban
* Thrombolytic therapy within 4 days before ASA check
* Contra-indication to aspirin or clopidogrel
* Recent major surgery \< 6 weeks
* Evidence of an active gastrointestinal or urogenital bleeding
* Severe liver insufficiency
* Primary PCI for acute MI
* Left main PCI
* Any scheduled surgery during the year after enrollment
* Severe concomitant disease with life expectation \< two years

Primary outcomes:
measure: composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding
timeFrame: one year
Secondary outcomes:
measure: composite endpoint:Death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding and minor bleeding
timeFrame: 36-month period
Other outcomes:
Locations:
city: Brest
country: France
facility: Department of cardiology
Study officials:
affiliation: Brest University France
name: martine Gilard, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilard M, Barragan P, Noryani AAL, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K, Benamer H, Kiss RG, Ungi I, Boschat J, Morice MC. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol. 2015 Mar 3;65(8):777-786. doi: 10.1016/j.jacc.2014.11.008. Epub 2014 Nov 16.