The ITALIC StudyIs There A LIfe for DES after discontinuation of Clopidogrel : The ITALIC Study - ITALIC
- Conditions
- Patients treated for PCI with at least one DES XIENCE implanted.
- Registration Number
- EUCTR2008-004131-38-FR
- Lead Sponsor
- French Society of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Male or female subject =18 years of age eligible for PCI with at least one DES 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Subjects not able to give informed consent
- 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 enrolment
- Severe concomitant disease with life expectation < two years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non inferiority of single ASA therapy compared with dual clopidogrel-ASA after six months following XIENCE DES implantation in good ASA responder patients.;Secondary Objective: To assess the bleeding complications at several time points: 12, 24 and 36 months.;Primary end point(s): Incidence at 12 months after XIENCE implantation of a composite endpoint of :<br> - death (cardiac and non cardiac)<br> - myocardial infarction<br> - repeat urgent revascularization <br> - stroke requiring a new hospitalisation<br> - major bleedings : according to the TIMI classification<br>
- Secondary Outcome Measures
Name Time Method