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

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.

Study Overview

• Status: Completed
• Conditions: Nonvalvular Atrial Fibrillation

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 Type: Observational
• Enrollment (Actual): 977

Contacts and Locations

Study Locations

• France
  • IIe-de-France
    • Paris, IIe-de-France, France, 75013
      • Geriatric Department, Broca Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients newly treated with Apixaban for non-valvular atrial fibrillation (no mechanical heart valves, no known moderate or severe mitral stenosis)

Description

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 .

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the incidence of bleeding events	12 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Olivier Hanon, MD PhD, Geriatric Department, Broca Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bleeding; Nonvalvular Atrial fibrillation; Apixaban.
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage
• Other Study ID Numbers: 2019-A03160-57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No