Bleeding Clinical Trial
Official title:
Evaluation of the Occurence of Thrombotic and Bleeding Events After Coronary Angioplasty With Stent According to Aspirin and Clopidogrel Platelet Reactivity Assessed by a Point of Care Assay in the Cathlab (the Verifynow French Registry)
The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as
measured by a point-of-care platelet function assay on thrombotic or bleeding events after
percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.
Methods:
Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow
(Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000
consecutive patients from 20 centers in France undergoing coronary angioplasty with stent.
Exclusion criteria are:
Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a
before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to
aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off
: < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of
definite or probable stent thrombosis (ARC definition) and the secondary end-points include
global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A
clinical evaluation is scheduled at discharge and by telephone contact at one month and one
year.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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