Antiplatelet Drug Resistances and Ischemic Events - Full Text View

Antiplatelet Drug Resistances and Ischemic Events (ADRIE)

This study is currently recruiting participants.

Verified by University Hospital, Geneva, June 2008

Sponsors and Collaborators:	University Hospital, Geneva Béziers Hospital, France University Hospital, Montpellier Ministry of Health, France Swiss National Science Foundation
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00501423

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

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Antiplatelet Drug Resistances and Ischemic Events

Further study details as provided by University Hospital, Geneva:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Contacts

Contact: Jean-Luc Reny, MD PhD	+33467357755	jean-luc.reny@ch-beziers.fr
Contact: Pierre Fontana, MD PhD	+41223795938	pierre.fontana@medecine.unige.ch

Locations

France
University Hospital Geneva; Beziers and Monpellier University Hospitals, France	Recruiting
Geneva - Beziers - Montpellier, France
Contact: Pierre Fontana, MD PhD +41223795938 pierre.fontana@medecine.unige.ch
Contact: Jean-Luc Reny, MD PhD +0033467337755 jean-luc.reny@ch-beziers.fr

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

Responsible Party:	Béziers Hospital and University Hospital Geneva ( P.Fontana and J.-L Reny )
Study ID Numbers:	06-034, CPP SUDMED IV 051201
Study First Received:	July 13, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00501423
Health Authority:	France: Ministry of Health; Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:

antiplatelet drug
resistance
atherothrombosis

Study placed in the following topic categories:

Ischemia

ClinicalTrials.gov processed this record on January 14, 2009