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Sponsors and Collaborators: |
Association Pour le Développement des Soins Cardiologiques de la ville de Chartres Medtronic Boston Scientific Corporation Cordis Corporation Abbott |
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Information provided by: | Association Pour le Développement des Soins Cardiologiques de la ville de Chartres |
ClinicalTrials.gov Identifier: | NCT00753753 |
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.
Condition |
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Stent Thrombosis Clopidogrel Aspirin Bleeding Angioplasty |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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) |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
real world patient referred for coronary angioplasty with stent
Inclusion Criteria:
Exclusion Criteria:
Contact: grégoire Rangé | 0678417001 | grange@ch-chartres.fr |
Contact: christophe thuaire | 0668530742 | cthuaire@ch-chartres..fr |
France, Eure Et Loir | |
cardiology unit / Les hopitaux de Chartres | Recruiting |
Chartres, Eure Et Loir, France, 28000 | |
Contact: gregoire rangé 0678417001 grange@ch-chartres.fr | |
Contact: christophe thuaire 0668530742 cthuaire@ch-chartres.fr | |
Principal Investigator: grégoire rangé |
Principal Investigator: | gregoire rangé | GACI |
Responsible Party: | cardiology unit / Chartres Hospital ( Dr Rangé grégoire ) |
Study ID Numbers: | VERIfynow FRENCH registrY, CPP n°2008-N2, AFFSAPS 2008-A00411-54 |
Study First Received: | September 15, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00753753 |
Health Authority: | France: Ministry of Health; France: Afssaps - French Health Products Safety Agency |
stent thrombosis clopidogrel aspirin |
bleeding coronary angioplasty |
Embolism and Thrombosis Aspirin Embolism Clopidogrel |
Vascular Diseases Hemorrhage Thrombosis |
Pathologic Processes Cardiovascular Diseases |