Status:
TERMINATED
The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Restenosis
Eligibility:
All Genders
18+ years
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
1235 Patients enrolled
Trial Details
Trial ID
NCT00780156
Start Date
November 1 2008
End Date
February 1 2013
Last Update
September 30 2013
Active Locations (1)
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1
department Cardiology
Brest, France, 29200