VerifyNow French Registry (VERIFRENCHY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Medtronic
Boston Scientific Corporation
Cordis Corporation
Abbott
Information provided by:
Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
ClinicalTrials.gov Identifier:
NCT00753753
First received: September 15, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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
Stent Thrombosis
Clopidogrel
Aspirin
Bleeding
Angioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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)

Resource links provided by NLM:


Further study details as provided by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres:

Primary Outcome Measures:
  • Stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2008
Estimated Study Completion Date: November 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

real world patient referred for coronary angioplasty with stent

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753753

Locations
France
cardiology unit / Les hopitaux de Chartres
Chartres, Eure Et Loir, France, 28000
Sponsors and Collaborators
Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
Medtronic
Boston Scientific Corporation
Cordis Corporation
Abbott
Investigators
Principal Investigator: gregoire rangé GACI
  More Information

No publications provided by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rangé grégoire, cardiology unit / Chartres Hospital
ClinicalTrials.gov Identifier: NCT00753753     History of Changes
Other Study ID Numbers: VERIfynow FRENCH registrY, CPP n°2008-N2, AFFSAPS 2008-A00411-54
Study First Received: September 15, 2008
Last Updated: August 3, 2009
Health Authority: France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres:
stent thrombosis
clopidogrel
aspirin
bleeding
coronary
angioplasty

Additional relevant MeSH terms:
Hemorrhage
Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014