Antiplatelet Drug Resistances and Ischemic Events (ADRIE)

January 30, 2014 updated by: Pierre Fontana
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

771

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Geneva - Beziers - Montpellier, France
        • University Hospital Geneva; Beziers and Monpellier University Hospitals, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Documented symptomatic ischemic atherothrombotic disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: prospective follow-up
adjudicating committee
prospective follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prospective follow-up

Other Outcome Measures

Outcome Measure
Time Frame
potential determinants of platelet reactivity
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fontana

Collaborators

Ministry of Health, France
University Hospital, Montpellier
Swiss National Science Foundation
Beziers Hospital

Investigators

  • Principal Investigator: Pierre Fontana, MD PhD, University Hospitals Geneva, Switzerland
  • Principal Investigator: Jean-Luc Reny, MD PhD, Beziers Hospital, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-034
  • CPP SUDMED IV 051201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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