Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04586972

Acronym

SOFIA

Enrollment

977

Registered

2020-10-14

Start date

2020-09-23

Completion date

2024-04-29

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonvalvular Atrial Fibrillation

Keywords

Nonvalvular Atrial fibrillation, Apixaban., Bleeding

Brief 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. 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)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* Patient refusing to participate. * Participation to a clinical trial. * Contraindication to use of Apixaban as described in the Summary of Product Characteristics .

Design outcomes

Primary

Measure	Time frame
Assessment of the incidence of bleeding events	12 months

Secondary

Measure	Time frame
To determine bleeding risk according (ATRIA bleeding) score	12 months
Assessment of compliance with treatment by (Apixaban) according (Morisky) Score	12 months
To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score	12 months
Assessment of the risk of bleeding according the (HAS-BLED) Score	12 months

Countries

France

Outcome results