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

NCT ID: NCT01476020

Last Updated: 2011-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Restenosis

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Organization and study management

UNKNOWN

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Gilard, Martine

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

martine Gilard, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Brest University France

Locations

Department of cardiology

Brest, , France

Countries

France

Central Contacts

Martine Gilard, MD, PhD

Role: CONTACT

Phone: +33 (0)2 98 34 75 05

Email: martine.gilard@chu-brest.fr

Facility Contacts

martine Gilard, MD, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25461690 (View on PubMed)

Other Identifiers

2011 08

Identifier Type: -

Identifier Source: org_study_id