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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00780156
Recruitment Status : Terminated (No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.)
First Posted : October 27, 2008
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
French Cardiology Society

Tracking Information
First Submitted Date October 24, 2008
First Posted Date October 27, 2008
Last Update Posted Date September 30, 2013
Study Start Date November 2008
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2013)
Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation [ Time Frame: 12 months ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel
Official Title The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study
Brief Summary

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

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients after drug eluting stent implantation
Condition Restenosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 8, 2013)
1235
Original Estimated Enrollment
 (submitted: October 24, 2008)
3200
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00780156
Other Study ID Numbers 2008-004131-38
2008-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party French Cardiology Society
Original Responsible Party French Cardiology Society, GACI
Current Study Sponsor French Cardiology Society
Original Study Sponsor Same as current
Collaborators Abbott Medical Devices
Investigators Not Provided
PRS Account French Cardiology Society
Verification Date September 2013