Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France
Study Details
Study Description
Brief Summary
The present study will be conducted to assess the following research questions in real-life conditions in France:
What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment?
What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients?
What are the conditions of newly-initiated apixaban prescriptions in NVAF patients:
prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- Patient characteristics in NVAF patients initiating a new AC-treatment [Approximately 12 months]
Patient's characteristics: age, gender, weight and height, BMI, dependence status
- Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients [Approximately 12 months]
- Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients [Approximately 12 months]
- Disease characteristics in NVAF patients initiating a new AC-treatment [Approximately 12 months]
Disease characteristics: type of NVAF (permanent, paroxystic, persistent) ALD status (ALD: Affections de Longue Duree) for long term disease status (ALD 5, other ALDs specified, any ALD), disease duration
- Comparing disease characteristics between apixaban and other NOACs in AC-naive patients [Approximately 12 months]
- Comparing disease characteristics between apixaban and VKAs in AC-naive patients [Approximately 12 months]
- Comorbidities in NVAF patients initiating a new AC-treatment [Approximately 12 months]
Comorbidities: congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding
- Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients [Approximately 12 months]
- Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients [Approximately 12 months]
- Treatment history in NVAF patients initiating a new AC-treatment [Approximately 12 months]
Treatment history: Previous AC strategy (no treatment, apixaban, other NOAC, VKAs) , Duration with previous AC strategy and indication of previous AC treatment
- Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients [Approximately 12 months]
- Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients [Approximately 12 months]
Secondary Outcome Measures
- Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs) [Approximately 12 months]
- Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment [Approximately 12 months]
Reason(s) for discontinuing previous AC strategy (multiple choices accepted): Minor Bleeding event, major bleeding event, gastro-intestinal bleeding, dosing frequency, high bleeding risk, fear of side effect, cost and concern with renal function, dyspepsia, frequent falls or frailty, patient decision, concomitant treatment, concomitant chronic disease
- Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other) [Approximately 12 months]
- Distribution of reasons for initiating a new AC treatment [Approximately 12 months]
- Distribution of reasons for choosing the newly initiated AC treatment [Approximately 12 months]
Reason(s) for choosing the newly initiated AC treatment (multiple choices accepted): Physician preference, patient preference, results of a specific trial in relation to the clinical setting, cost and dosing frequency
- Conditions of prescription of apixaban in NVAF patients [Approximately 12 months]
Condition of prescription of apixaban: Daily dosage (mg) at apixaban initiation, number of doses per day at apixaban initiation
- Proportion of AC-naive patients [Approximately 12 months]
- Proportion of AC-experienced patients [Approximately 12 months]
- Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics [Approximately 12 months]
- Mean number of daily doses for prescribed apixaban treatment according to patient characteristics [Approximately 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged ≥ 18 years
-
Diagnosed with non valvular atrial fibrillation (NVAF)
-
Prescribed with a newly initiated AC treatment (apixaban, other NOACs or VKAs). Newly initiated AC treatment is defined as any AC treatment initiated within the past 3 months, including day of enrolment
Exclusion Criteria:
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Patients with atrial fibrillation (AF) due to reversible causes
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Patients with a diagnosis of VAF. The term VAF is used to imply that AF is related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves
-
Patients participating in an ongoing clinical trial in AF
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Fontaine Les Dijon | France | 21121 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV185-345