Antiplatelet Drug Resistances and Ischemic Events

NCT ID: NCT00501423

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

771 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Symptomatic Atherothrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beziers Hospital

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Pierre Fontana

OTHER

Sponsor Role lead

Responsible Party

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Pierre Fontana

PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pierre Fontana, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Geneva, Switzerland

Jean-Luc Reny, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Beziers Hospital, France

Locations

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University Hospital Geneva; Beziers and Monpellier University Hospitals, France

Geneva - Beziers - Montpellier, , France

Site Status

Countries

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France

References

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Reny JL, Berdague P, Poncet A, Barazer I, Nolli S, Fabbro-Peray P, Schved JF, Bounameaux H, Mach F, de Moerloose P, Fontana P; Antiplatelet Drug Resistances and Ischemic Events (ADRIE) Study Group. Antiplatelet drug response status does not predict recurrent ischemic events in stable cardiovascular patients: results of the Antiplatelet Drug Resistances and Ischemic Events study. Circulation. 2012 Jun 26;125(25):3201-10. doi: 10.1161/CIRCULATIONAHA.111.085464. Epub 2012 May 21.

Reference Type DERIVED
PMID: 22615340 (View on PubMed)

Fontana P, James R, Barazer I, Berdague P, Schved JF, Rebsamen M, Vuilleumier N, Reny JL. Relationship between paraoxonase-1 activity, its Q192R genetic variant and clopidogrel responsiveness in the ADRIE study. J Thromb Haemost. 2011 Aug;9(8):1664-6. doi: 10.1111/j.1538-7836.2011.04409.x. No abstract available.

Reference Type DERIVED
PMID: 21692977 (View on PubMed)

Other Identifiers

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CPP SUDMED IV 051201

Identifier Type: -

Identifier Source: secondary_id

06-034

Identifier Type: -

Identifier Source: org_study_id

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