Status:
UNKNOWN
Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel
Lead Sponsor:
Gilard, Martine
Collaborating Sponsors:
Clinical Research Organization and study management
Abbott Medical Devices
Conditions:
Restenosis
Eligibility:
All Genders
18+ years
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 si...
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 thromb...
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 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
1240 Patients enrolled
Trial Details
Trial ID
NCT01476020
Start Date
November 1 2011
End Date
July 1 2015
Last Update
November 22 2011
Active Locations (1)
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1
Department of cardiology
Brest, France, 29 609 Cedex