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Antiplatelet Drug Resistances and Ischemic Events (ADRIE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501423
First Posted: July 16, 2007
Last Update Posted: January 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Béziers Hospital, France
University Hospital, Montpellier
Ministry of Health, France
Swiss National Science Foundation
Information provided by (Responsible Party):
Pierre Fontana, University Hospital, Geneva
  Purpose
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

Condition
Symptomatic Atherothrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiplatelet Drug Resistances and Ischemic Events

Resource links provided by NLM:


Further study details as provided by Pierre Fontana, University Hospital, Geneva:

Primary Outcome Measures:
  • MACE [ Time Frame: prospective follow-up ]
    adjudicating committee


Secondary Outcome Measures:
  • MACE in pre-specified sub-groups [ Time Frame: prospective follow-up ]
    patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry


Other Outcome Measures:
  • potential determinants of platelet reactivity [ Time Frame: at inclusion ]

Enrollment: 771
Study Start Date: June 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

Main objective:

  • to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of ischemic events during the 3-year follow-up.

Secondary objectives:

  • primary outcome in each pre-specified sub-group : patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry,
  • to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of bleeding events during the 3-year follow-up,
  • to investigate potential determinants of platelet reactivity at entry in the study
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Documented symptomatic ischemic atherothrombotic disease
Criteria

Inclusion Criteria:

  • Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both.

Exclusion Criteria:

  • Known platelet disorder
  • Chronic treatment by antiplatelet drugs other than aspirin or clopidogrel.
  • Chronic anticoagulant treatment
  • Chronic non steroid anti inflammatory drug treatment
  • Active cancer
  • Ongoing aspirin or clopidogrel treatment taken for more than 5 years prior to inclusion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501423


Locations
France
University Hospital Geneva; Beziers and Monpellier University Hospitals, France
Geneva - Beziers - Montpellier, France
Sponsors and Collaborators
Pierre Fontana
Béziers Hospital, France
University Hospital, Montpellier
Ministry of Health, France
Swiss National Science Foundation
Investigators
Principal Investigator: Pierre Fontana, MD PhD University Hospitals Geneva, Switzerland
Principal Investigator: Jean-Luc Reny, MD PhD Beziers Hospital, France
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Fontana, PI, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00501423     History of Changes
Other Study ID Numbers: 06-034
CPP SUDMED IV 051201
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: January 31, 2014
Last Verified: January 2014

Keywords provided by Pierre Fontana, University Hospital, Geneva:
antiplatelet drug
resistance
atherothrombosis

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors