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
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: 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014