Antiplatelet Drug Resistances and Ischemic Events

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00501423

Acronym

ADRIE

Enrollment

771

Registered

2007-07-16

Start date

2006-06-30

Completion date

2010-09-30

Last updated

2014-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Atherothrombosis

Keywords

antiplatelet drug, resistance, atherothrombosis

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MACE	prospective follow-up	adjudicating committee

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame
potential determinants of platelet reactivity	at inclusion

Countries

France

Outcome results