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

Nonvalvular Atrial Fibrillation Clinical Trial

— SOFIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586972
• Other study ID #: 2019-A03160-57
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: Gérond'if
• Contact: Isabelle Dufour
• Phone: +33 (0) 185781011
• Email: isabelle.dufour[@]gerondif.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.

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")

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 976
• Est. completion date: February 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Atrial Fibrillation
• Nonvalvular Atrial Fibrillation

Locations

Country	Name	City	State
France	Geriatric Department, Broca Hospital	Paris	IIe-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the incidence of bleeding events		12 months
Secondary	To determine bleeding risk according (ATRIA bleeding) score		12 months
Secondary	Assessment of compliance with treatment by (Apixaban) according (Morisky) Score		12 months
Secondary	To quantifie risk of hemorrhage according (HEMORR2HAGES) Score		12 months
Secondary	Assessment of the risk of bleeding according the (HAS-BLED) Score		12 months