Antiplatelet Drug Resistances and Ischemic Events (ADRIE)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by University Hospital, Geneva.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Béziers Hospital, France

University Hospital, Montpellier

Ministry of Health, France

Swiss National Science Foundation

Information provided by:

University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT00501423

First received: July 13, 2007

Last updated: September 9, 2009

Last verified: September 2009

History of Changes

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:

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Estimated Enrollment:	800
Study Start Date:	June 2006
Estimated Study Completion Date:	July 2011

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

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

University Hospital, Geneva

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):

Reny JL, Berdagué 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. Epub 2012 May 21.

Fontana P, James R, Barazer I, Berdagué 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. No abstract available.

Responsible Party:	P.Fontana and J.-L Reny, Béziers Hospital and 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:	September 9, 2009
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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