Clinical trial NCT00501423: Antiplatelet Drug Resistances and Ischemic Events
Official title: Antiplatelet Drug Resistances and Ischemic Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Atherothrombosis
Keywords: antiplatelet drug
resistance
atherothrombosis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Beziers Hospital
name: University Hospital, Montpellier
name: Ministry of Health, France
name: Swiss National Science Foundation
First posted: 2007-07-16
Enrollment: 771
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Documented symptomatic ischemic atherothrombotic disease

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

Eligibility 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

Primary outcomes:
measure: MACE
timeFrame: prospective follow-up
Secondary outcomes:
measure: MACE in pre-specified sub-groups
timeFrame: prospective follow-up
Other outcomes:
measure: potential determinants of platelet reactivity
timeFrame: at inclusion
Locations:
city: Geneva - Beziers - Montpellier
country: France
facility: University Hospital Geneva; Beziers and Monpellier University Hospitals, France
Study officials:
affiliation: University Hospitals Geneva, Switzerland
name: Pierre Fontana, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beziers Hospital, France
name: Jean-Luc Reny, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.