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

NCT04586972 | Completed DMC

• 1 other identifier: 2019-A03160-57
• Study Type: observational
• Target: 977
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonvalvular Atrial Fibrillation

Keywords

Nonvalvular Atrial fibrillation; Apixaban.; Bleeding

Outcome Measures

Primary Outcomes (1)

• Assessment of the incidence of bleeding events

  12 months

Secondary Outcomes (4)

• 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

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Hanon, MD PhD

  Geriatric Department, Broca hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 14, 2020
• Study Start: September 23, 2020
• Primary Completion: December 21, 2023
• Study Completion: April 29, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)