Clinical trial NCT00753753: VerifyNow French Registry
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stent Thrombosis
Clopidogrel
Aspirin
Bleeding
Angioplasty
Keywords: stent thrombosis
clopidogrel
aspirin
bleeding
coronary
angioplasty
Lead sponsor: Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Boston Scientific Corporation
name: Cordis Corporation
name: Abbott
First posted: 2008-09-16
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: real world patient referred for coronary angioplasty with stent

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stent thrombosis
timeFrame: one year
Secondary outcomes:
measure: Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding
timeFrame: one year
Other outcomes:
Locations:
city: Chartres
country: France
facility: cardiology unit / Les hopitaux de Chartres
state: Eure Et Loir
Study officials:
affiliation: GACI
name: gregoire rangé
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.