NCT00501423

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
771

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

4.3 years

First QC Date

July 13, 2007

Last Update Submit

January 30, 2014

Conditions

Keywords

antiplatelet drugresistanceatherothrombosis

Outcome Measures

Primary Outcomes (1)

  • MACE

    adjudicating committee

    prospective follow-up

Secondary Outcomes (1)

  • MACE in pre-specified sub-groups

    prospective follow-up

Other Outcomes (1)

  • potential determinants of platelet reactivity

    at inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Documented symptomatic ischemic atherothrombotic disease

You may qualify if:

  • Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva; Beziers and Monpellier University Hospitals, France

Geneva - Beziers - Montpellier, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Pierre Fontana, MD PhD

    University Hospitals Geneva, Switzerland

    PRINCIPAL INVESTIGATOR
  • Jean-Luc Reny, MD PhD

    Beziers Hospital, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

June 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations