Atrial FibrillationAOD-SANCT02894450
Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years
An observational study of Atrial Fibrillation, run by Nantes University Hospital at 1 site in France.
Trial summary
The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- blood test
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients over 75 years under anticoagulant treatment 'xaban' (dabigatran, rivaroxaban, Apixaban) for atrial fibrillation, hospital unscheduled manner in Medicine and Geriatric services Versatile Service Home Emergency CHU Nantes and where a hemostatic balance is expected to be offered the study. The recruitment will be made on a 6-month period (November 2014 - April 2015). Bioassay 'xaban' will be made from the remainder of the tube removed for hemostasis tests provided in the usual care of patients.
Who may be able to join
- Age ≥ 75 years
- Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)
- In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation
- In whom hemostasis tests will be prescribed as part of usual care
- Patient has given its verbal agreement
Who cannot join
- Patients with the following criteria may not be included:
- Patients refusing to participate in the study
- Patients under guardianship
- Inability to obtain the date and time of the last dose of xaban
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation
The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.
- Conditions
- Atrial Fibrillation
- Being tested
- blood test
- Keywords
- Atrial fibrillation, oral anticoagulant, bioassay, elderly subject
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
bioassay xaban
What is being measured
The primary outcome is the main question the study is designed to answer.
bioassay direct oral anticoagulants
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Chevalet, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894450
- Sponsor's protocol ID
- RC14_0402
- Acronym
- AOD-SA
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02894450
- Acronym / sponsor ID
- AOD-SA / RC14_0402
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, oral anticoagulant, bioassay, elderly subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Sep 2016 (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 objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients over 75 years under anticoagulant treatment 'xaban' (dabigatran, rivaroxaban, Apixaban) for atrial fibrillation, hospital unscheduled manner in Medicine and Geriatric services Versatile Service Home Emergency CHU Nantes and where a hemostatic balance is expected to be offered the study. The recruitment will be made on a 6-month period (November 2014 - April 2015). Bioassay 'xaban' will be made from the remainder of the tube removed for hemostasis tests provided in the usual care of patients.
Key inclusion criteria (5 listed)
- Age ≥ 75 years
- Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)
- In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation
- In whom hemostasis tests will be prescribed as part of usual care
- Patient has given its verbal agreement
Key exclusion criteria (4 listed)
- Patients refusing to participate in the study
- Patients under guardianship
- Inability to obtain the date and time of the last dose of xaban
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testbioassay xaban | Other | – |
Primary outcome
bioassay direct oral anticoagulants
Time frame: Baseline
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 24 Jun 2026.
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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.
Pascal Chevalet, Dr principal investigator
Nantes University Hospital
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 Atrial Fibrillation, run by Nantes University Hospital 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 5 inclusion and 4 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 24 Jun 2026. 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?
bioassay direct oral anticoagulants (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.