VerifyNow French Registry

Bleeding Clinical Trial

— VERIFRENCHY  

Official title:

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)

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

Related Conditions & MeSH terms

• Angioplasty
• Aspirin
• Bleeding
• Clopidogrel
• Hemorrhage
• Stent Thrombosis
• Thrombosis

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