Patients treated for PCI with at least one DES XIENCE implanted.
Conditions
Interventions
Product Name: acide acetyl salicylique
Pharmaceutical Form: Oral powder
INN or Proposed INN: Acid acetyl salicylique
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration
Sponsors
French Society of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 : - death (cardiac and non cardiac) - myocardial infarction - repeat urgent revascularization - stroke requiring a new hospitalisation - major bleedings : according to the TIMI classification | — |
Countries
France
Outcome results
None listed