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OpenTrials
Completed

NCT Number: NCT00753753

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.

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Key information

Conditions

Stent Thrombosis Angioplasty Aspirin Bleeding Clopidogrel Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

cardiology unit / Les hopitaux de Chartres

Chartres, Eure Et Loir, 28000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Stent thrombosis

    Time frame: one year

Secondary outcomes

  1. Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding

    Time frame: one year

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Abbott
  • Boston Scientific Corporation
  • Cordis US Corp.
  • Medtronic

Registry information

Official study 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)

Acronym: VERIFRENCHY

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 16, 2008
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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