SOFIA: Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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 18 months in each center.
The follow-up period starts 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:
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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.
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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.
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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 Design
Outcome Measures
Primary Outcome Measures
- Assessment of the incidence of bleeding events [12 months]
Secondary Outcome Measures
- 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
Criteria
Inclusion Criteria:
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Male or female patients aged 80 years and older.
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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).
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Followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes).
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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:
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Patient refusing to participate.
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Participation to a clinical trial.
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Contraindication to use of Apixaban as described in the Summary of Product Characteristics .
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Geriatric Department, Broca Hospital | Paris | IIe-de-France | France | 75013 |
Sponsors and Collaborators
- Gérond'if
Investigators
- Study Chair: Olivier Hanon, MD PhD, Geriatric Department, Broca hospital,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-A03160-57