The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel

This study has been terminated.
(No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.)
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00780156
First received: October 24, 2008
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

Background

Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need for repeat revascularization procedures in patients who undergo PCI. The potential increased incidence of late stent thrombosis prompted cardiologists to prolong the use of dual anti-platelet therapy after the one year duration recommended by the recent ESC guidelines. However, while the premise that the cardiologists should put all their patients on dual clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because of the potential increase of bleeding complications and of the healthcare cost increase. The recent possibility to monitor aspirin with bedside assays offers a real opportunity to compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen versus mono-aspirin regimen and to respond to the key question: can the investigators switch from dual to single antiplatelet therapy after six months in good aspirin responder patients ? Study National, multicenter, randomised prospective open group comparison of dual clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients treated with DES (name: XIENCE) implantation.

End point Primary: At 12 months: death, myocardial infarction, repeat urgent revascularization, stroke requiring a new hospitalisation and major bleedings.

Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation, of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding complications Participating centres: 60 french centers

Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45 months


Condition
Restenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1235
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients after drug eluting stent implantation

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780156

Locations
France
department Cardiology
Brest, France, 29200
Sponsors and Collaborators
French Cardiology Society
Abbott Vascular
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00780156     History of Changes
Other Study ID Numbers: 2008-004131-38, 2008-02
Study First Received: October 24, 2008
Last Updated: September 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French Cardiology Society:
Drug eluting stent
Dual antiplatelet therapy
bleeding
stent thrombosis
follow-up of the drug eluting stent

Additional relevant MeSH terms:
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014