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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00753753
Other study ID # VERIfynow FRENCH registrY
Secondary ID CPP n°2008-N2AFF
Status Completed
Phase N/A
First received September 15, 2008
Last updated June 24, 2015
Start date February 2008
Est. completion date November 2009

Study information

Verified date June 2015
Source Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1001
Est. completion date November 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
France cardiology unit / Les hopitaux de Chartres Chartres Eure Et Loir

Sponsors (5)

Lead Sponsor Collaborator
Association Pour le Développement des Soins Cardiologiques de la ville de Chartres Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stent thrombosis one year Yes
Secondary Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding one year Yes
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