Nonvalvular Atrial FibrillationSOFIANCT04586972
Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
An observational study of Nonvalvular Atrial Fibrillation, run by Gérond'if at 1 site in France.
Trial summary
The main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- How many people
- 977 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2020to 29 Apr 2024
- How long will I take part?
- 1 Year
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients newly treated with Apixaban for non-valvular atrial fibrillation (no mechanical heart valves, no known moderate or severe mitral stenosis)
Who may be able to join
- Male or female patients aged 80 years and older.
- Patients with non-valvular atrial fibrillation (documented on electrocardiography or other medical evidence like medical chart, hospital discharge note, physician's letter within 3 years before enrollment).
- Followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes).
- Newly treated (less than 6 months) with Apixaban (5mg twice daily (or 2.5 mg twice daily for patients with 2 of the following criteria : age > 80 years, creatinine > 133 μmol/l, weight < 60 kg)
Who cannot join
- Patient refusing to participate.
- Participation to a clinical trial.
- Contraindication to use of Apixaban as described in the Summary of Product Characteristics .
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban.
Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.
Read the detailed description
It is a muliticentric, observational, prospective study.
This study will be conducted in about 40 geriatric settings in France.
The planned duration of the inclusion period is 27 months in each center.
The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3, 6, 9 and 12 months.
During this follow-up, participants physicians will record patients' data during visit directly from the patients or their physicians or their families and by phone.
The following data will be colllected:
- At M0 : Socio-demographics, clinical and biological data; embolic risk and emorrhagic risk scores,cognitive function, number of falls, blood pressure, nutritional assessment, athonomy, comorbidities, data on anticoagulant therapy, treatment discontinuation and clinical evaluation.
- At M3, M6, M9 and M12: • Number of falls, all treatment schedule, record of major bleeding events, record of any other bleeding events, record of other serious events, record of other non-major events, treatment discontinuation, and social and medical environment.
- Only M6 and M12: Renal function (both Cockcroft-Gault, chronic Kidney Disease, epidemiology Collaboration "CKD EPI" and the four variable modification of Diet in renal Disease equation "MDRD")
- Conditions
- Nonvalvular Atrial Fibrillation
- Keywords
- Nonvalvular Atrial fibrillation, Apixaban., Bleeding
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of bleeding events
Measured: 12 months
Secondary outcomes (4)
To determine bleeding risk according (ATRIA bleeding) score
Measured: 12 months
Assessment of compliance with treatment by (Apixaban) according (Morisky) Score
Measured: 12 months
To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score
Measured: 12 months
Assessment of the risk of bleeding according the (HAS-BLED) Score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Sep 2020
- Primary completion21 Dec 2023
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 977 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Geriatric Department, Broca hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586972
- Sponsor's protocol ID
- 2019-A03160-57
- Acronym
- SOFIA
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
- ClinicalTrials.gov ID
- NCT04586972
- Acronym / sponsor ID
- SOFIA / 2019-A03160-57
- Conditions
- Nonvalvular Atrial Fibrillation
- Keywords
- Nonvalvular Atrial fibrillation, Apixaban., Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- 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 main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban.
Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.
Detailed description
It is a muliticentric, observational, prospective study.
This study will be conducted in about 40 geriatric settings in France.
The planned duration of the inclusion period is 27 months in each center.
The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3, 6, 9 and 12 months.
During this follow-up, participants physicians will record patients' data during visit directly from the patients or their physicians or their families and by phone.
The following data will be colllected:
- At M0 : Socio-demographics, clinical and biological data; embolic risk and emorrhagic risk scores,cognitive function, number of falls, blood pressure, nutritional assessment, athonomy, comorbidities, data on anticoagulant therapy, treatment discontinuation and clinical evaluation.
- At M3, M6, M9 and M12: • Number of falls, all treatment schedule, record of major bleeding events, record of any other bleeding events, record of other serious events, record of other non-major events, treatment discontinuation, and social and medical environment.
- Only M6 and M12: Renal function (both Cockcroft-Gault, chronic Kidney Disease, epidemiology Collaboration "CKD EPI" and the four variable modification of Diet in renal Disease equation "MDRD")
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients newly treated with Apixaban for non-valvular atrial fibrillation (no mechanical heart valves, no known moderate or severe mitral stenosis)
Key inclusion criteria (4 listed)
- Male or female patients aged 80 years and older.
- Patients with non-valvular atrial fibrillation (documented on electrocardiography or other medical evidence like medical chart, hospital discharge note, physician's letter within 3 years before enrollment).
- Followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes).
- Newly treated (less than 6 months) with Apixaban (5mg twice daily (or 2.5 mg twice daily for patients with 2 of the following criteria : age > 80 years, creatinine > 133 μmol/l, weight < 60 kg)
Key exclusion criteria (3 listed)
- Patient refusing to participate.
- Participation to a clinical trial.
- Contraindication to use of Apixaban as described in the Summary of Product Characteristics .
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
Assessment of the incidence of bleeding events
Time frame: 12 months
4 secondary outcomes
To determine bleeding risk according (ATRIA bleeding) score
Time frame: 12 months
Assessment of compliance with treatment by (Apixaban) according (Morisky) Score
Time frame: 12 months
To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score
Time frame: 12 months
Assessment of the risk of bleeding according the (HAS-BLED) Score
Time frame: 12 months
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 16 Sep 2025.
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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.
Olivier Hanon, MD PhD study chair
Geriatric Department, Broca 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 Nonvalvular Atrial Fibrillation, run by Gérond'if 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 4 inclusion and 3 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 16 Sep 2025. 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?
Assessment of the incidence of bleeding events (time frame: 12 months). 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 16 Sep 2025.