VerifyNow French Registry (VERIFRENCHY)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Medtronic

Boston Scientific Corporation

Cordis Corporation

Abbott

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00753753

First received: September 15, 2008

Last updated: August 3, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2008

Last Updated Date

August 3, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00753753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Mortality, cardio-vascular mortality, severe bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

VerifyNow French Registry

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

real world patient referred for coronary angioplasty with stent

Condition ^ICMJE

Stent Thrombosis
Clopidogrel
Aspirin
Bleeding
Angioplasty

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

November 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00753753

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

Responsible Party

Dr Rangé grégoire, cardiology unit / Chartres Hospital

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Medtronic
Boston Scientific Corporation
Cordis Corporation
Abbott

Investigators ^ICMJE

Principal Investigator:

gregoire rangé

GACI

Information Provided By

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

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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