Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel (ITALICplus)

• ClinicalTrials.gov Identifier: NCT01476020
• Recruitment Status: Unknown
• First Posted: November 22, 2011
• Last Update Posted: November 22, 2011
• Sponsor: Gilard, Martine
• Collaborators: Clinical Research Organization and study management; Abbott Medical Devices
• Information provided by (Responsible Party): Gilard, Martine

Study Description

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.

Condition or disease
Restenosis

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 1240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial
• Study Start Date: November 2011
• Estimated Primary Completion Date: July 2012
• Estimated Study Completion Date: July 2015

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding [ Time Frame: one year ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Subjects are selected from the general population needing Percutaneous Coronary Interventions (PCI).

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

Contacts and Locations

Contacts

Contact: Martine Gilard, MD, PhD; +33 (0)2 98 34 75 05; martine.gilard@chu-brest.fr

Locations

France

Department of cardiology

Brest, France, 29 609 Cedex

Contact: martine Gilard, MD, PhD +33 (0)2 98 34 75 05 martine.gilard@chu-brest.fr

Principal Investigator: Martine Gilard, MD, PhD

Sponsors and Collaborators

Gilard, Martine

Clinical Research Organization and study management

Abbott Medical Devices

Investigators

• Principal Investigator: martine Gilard, MD,PhD; Brest University France

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gilard, Martine
• ClinicalTrials.gov Identifier: NCT01476020
• Other Study ID Numbers: 2011 08
• First Posted: November 22, 2011
• Last Update Posted: November 22, 2011
• Last Verified: November 2011

Keywords provided by Gilard, Martine:

Drug eluting stent; Dual antiplatelet therapy; bleeding; stent thrombosis; follow-up of the drug eluting stent