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VerifyNow French Registry

NCT00753753 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1001

Last updated 2015-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Stent Thrombosis
  • Clopidogrel
  • Aspirin
  • Bleeding
  • Angioplasty

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Cordis Corporation

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • gregoire rangé · GACI

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-10-31
Completion
2009-11-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753753 on ClinicalTrials.gov