Antiplatelet Drug Resistances and Ischemic Events (ADRIE)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00501423
First received: July 13, 2007
Last updated: January 30, 2014
Last verified: January 2014
  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 University Hospital, Geneva:

Primary Outcome Measures:
  • MACE [ Time Frame: prospective follow-up ] [ Designated as safety issue: No ]
    adjudicating committee


Secondary Outcome Measures:
  • MACE in pre-specified sub-groups [ Time Frame: prospective follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Geneva

Additional 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
Study First Received: July 13, 2007
Last Updated: January 30, 2014
Health Authority: France: Ministry of Health
Switzerland: Federal Office of Public Health

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

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014