Antiplatelet Drug Resistances and Ischemic Events

Completed

• Conditions: Symptomatic Atherothrombosis

• Registration Number: NCT00501423
• Lead Sponsor: Pierre Fontana

Brief Summary

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

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 771

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	prospective follow-up	adjudicating committee

Secondary Outcome Measures

Name	Time	Method
MACE in pre-specified sub-groups	prospective follow-up	patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry

Trial Locations

Locations (1)

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