Symptomatic AtherothrombosisADRIENCT00501423
Antiplatelet Drug Resistances and Ischemic Events
An observational study of Symptomatic Atherothrombosis, run by Pierre Fontana at 1 site in France.
Trial summary
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Atherothrombosis
- How many people
- 771 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Documented symptomatic ischemic atherothrombotic disease
Who may be able to join
- Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Geneva; Beziers and Monpellier University Hospitals, France
Geneva - Beziers - Montpellier
About this study
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.
Read the 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
- Conditions
- Symptomatic Atherothrombosis
- Keywords
- antiplatelet drug, resistance, atherothrombosis
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
adjudicating committee
Measured: prospective follow-up
Secondary outcomes (1)
MACE in pre-specified sub-groups
patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry
Measured: prospective follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJun 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic AtherothrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fontana
- Sponsor type
- University, hospital or other
- Collaborators
- Beziers Hospital, University Hospital, Montpellier, Ministry of Health, France, Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Pierre Fontana, University Hospital, Geneva
- Investigators
- Pierre Fontana, MD PhD, Principal investigator, University Hospitals Geneva, SwitzerlandJean-Luc Reny, MD PhD, Principal investigator, Beziers Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501423
- Sponsor's protocol ID
- 06-034
- Other IDs
- CPP SUDMED IV 051201
- Acronym
- ADRIE
- Status last verified
- Jan 2014
- First submitted
- 13 Jul 2007
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22615340Fontana 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.
PubMed 21692977
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Drug Resistances and Ischemic Events
- ClinicalTrials.gov ID
- NCT00501423
- Acronym / sponsor ID
- ADRIE / 06-034
- Conditions
- Symptomatic Atherothrombosis
- Keywords
- antiplatelet drug, resistance, atherothrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Pierre FontanaUniversity, hospital or other
- Collaborators
- Beziers Hospital, University Hospital, Montpellier, Ministry of Health, France, Swiss National Science Foundation
- Study start
- Jun 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Documented symptomatic ischemic atherothrombotic disease
Key inclusion criteria (1 listed)
- Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: prospective follow-up
adjudicating committee
1 secondary outcome
MACE in pre-specified sub-groups
Time frame: prospective follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Derived from this study: PubMed 22615340Reny 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.
- Derived from this study: PubMed 21692977Fontana 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fontana, MD PhD principal investigator
University Hospitals Geneva, Switzerland
Jean-Luc Reny, MD PhD principal investigator
Beziers Hospital, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Atherothrombosis, run by Pierre Fontana at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: prospective follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.