Nonvalvular Atrial Fibrillation Clinical Trial
— SOFIAOfficial title:
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.
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 . |
Country | Name | City | State |
---|---|---|---|
France | Geriatric Department, Broca Hospital | Paris | IIe-de-France |
Lead Sponsor | Collaborator |
---|---|
Gérond'if |
France,
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 |
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