VerifyNow French Registry

NCT00753753 | Completed DMC

• 3 other identifiers: VERIfynow FRENCH registrYCPP n°2008-N2AFFSAPS 2008-A00411-54
• Study Type: observational
• Target: 1,001
• Locations: 1 country
• Sites: 1

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.

Conditions

Stent Thrombosis; Clopidogrel; Aspirin; Bleeding; Angioplasty

Keywords

stent thrombosis; clopidogrel; aspirin; bleeding; coronary; angioplasty

Outcome Measures

Primary Outcomes (1)

• Stent thrombosis

  one year

Secondary Outcomes (1)

• Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

real world patient referred for coronary angioplasty with stent

You may qualify if:

• Coronary angioplasty with stent

You may not qualify if:

• Use of AGP2b3a
• Acute myocardial infarction
• No aspirin and clopidogrel pretreatment
• Use of AVK
• Aspirin or clopidogrel contre-indication

Sponsors & Collaborators

• Association Pour le Développement des Soins Cardiologiques de la ville de Chartres: lead
• Medtronic: collaborator
• Boston Scientific Corporation: collaborator
• Cordis US Corp.: collaborator
• Abbott: collaborator

Study Sites (1)

cardiology unit / Les hopitaux de Chartres

Chartres, Eure Et Loir, 28000, France

Location

Related Publications (1)

• 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.

  PMID: 24794216 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• gregoire rangé

  GACI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2009
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

FR (1)