VerifyNow French Registry (VERIFRENCHY)
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.
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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)|
- Stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753753
|cardiology unit / Les hopitaux de Chartres|
|Chartres, Eure Et Loir, France, 28000|
|Principal Investigator:||gregoire rangé||GACI|