VerifyNow French Registry (VERIFRENCHY)

Association Pour le Développement des Soins Cardiologiques de la ville de Chartres

Status: Completed

Conditions: Clopidogrel; Angioplasty; Aspirin; Bleeding; Stent Thrombosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00753753

CPP n°2008-N2

VERIfynow FRENCH registrY

AFFSAPS 2008-A00411-54

Details and patient eligibility

About

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.

Enrollment: 1,001 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary angioplasty with stent

Exclusion criteria

• Use of AGP2b3a
• Acute myocardial infarction
• No aspirin and clopidogrel pretreatment
• Use of AVK
• Aspirin or clopidogrel contre-indication