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Completed

NCT Number: NCT04586972

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

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

About this study

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")

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Primary outcomes

  1. Assessment of the incidence of bleeding events

    Time frame: 12 months

Secondary outcomes

  1. To determine bleeding risk according (ATRIA bleeding) score

    Time frame: 12 months

  2. Assessment of compliance with treatment by (Apixaban) according (Morisky) Score

    Time frame: 12 months

  3. To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score

    Time frame: 12 months

  4. Assessment of the risk of bleeding according the (HAS-BLED) Score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: SOFIA

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Oct 14, 2020
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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