VerifyNow French Registry (VERIFRENCHY)

June 24, 2015 updated by: RANGE Gregoire, Association Pour le Développement des Soins Cardiologiques de la ville de Chartres

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Eure Et Loir
      • Chartres, Eure Et Loir, France, 28000
        • cardiology unit / Les hopitaux de Chartres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

real world patient referred for coronary angioplasty with stent

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Boston Scientific Corporation
Medtronic
Abbott
Cordis Corporation

Investigators

  • Principal Investigator: gregoire rangé, GACI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERIfynow FRENCH registrY
  • CPP n°2008-N2
  • AFFSAPS 2008-A00411-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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