VerifyNow French Registry

NCT ID: NCT00753753

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1001 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stent Thrombosis Clopidogrel Aspirin Bleeding Angioplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Cordis Corporation

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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RANGE Gregoire

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gregoire rangé

Role: PRINCIPAL_INVESTIGATOR

GACI

Locations

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cardiology unit / Les hopitaux de Chartres

Chartres, Eure Et Loir, France

Site Status

Countries

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France

References

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Range G, Yayehd K, Belle L, Thuaire C, Richard P, Cazaux P, Barbou F, Koning R, Chassaing S, Teiger E, Berthier R, Decomis MP, Claudel JP, Delarche N, Brunel P, De Poli F, Dupouy P, Beygui F, Albert F, Collet JP, Montalescot G; VERIFRENCHY investigators. Thrombotic and bleeding events after coronary stenting according to clopidogrel and aspirin platelet reactivity: VerifyNow French Registry (VERIFRENCHY). Arch Cardiovasc Dis. 2014 Apr;107(4):225-35. doi: 10.1016/j.acvd.2014.03.004. Epub 2014 Apr 29.

Reference Type DERIVED
PMID: 24794216 (View on PubMed)

Other Identifiers

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CPP n°2008-N2

Identifier Type: -

Identifier Source: secondary_id

AFFSAPS 2008-A00411-54

Identifier Type: -

Identifier Source: secondary_id

VERIfynow FRENCH registrY

Identifier Type: -

Identifier Source: org_study_id

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