Clinical trial NCT02714855: Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France
Official title: Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 2081
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiologists in france caring AF patients

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?


Eligibility 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:

* Patients with atrial fibrillation (AF) due to reversible causes
* 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

Primary outcomes:
measure: Patient characteristics in NVAF patients initiating a new AC-treatment
timeFrame: Approximately 12 months
measure: Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients
timeFrame: Approximately 12 months
measure: Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients
timeFrame: Approximately 12 months
measure: Disease characteristics in NVAF patients initiating a new AC-treatment
timeFrame: Approximately 12 months
measure: Comparing disease characteristics between apixaban and other NOACs in AC-naive patients
timeFrame: Approximately 12 months
measure: Comparing disease characteristics between apixaban and VKAs in AC-naive patients
timeFrame: Approximately 12 months
measure: Comorbidities in NVAF patients initiating a new AC-treatment
timeFrame: Approximately 12 months
measure: Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients
timeFrame: Approximately 12 months
measure: Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients
timeFrame: Approximately 12 months
measure: Treatment history in NVAF patients initiating a new AC-treatment
timeFrame: Approximately 12 months
measure: Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients
timeFrame: Approximately 12 months
measure: Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)
timeFrame: Approximately 12 months
measure: Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment
timeFrame: Approximately 12 months
measure: Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)
timeFrame: Approximately 12 months
measure: Distribution of reasons for initiating a new AC treatment
timeFrame: Approximately 12 months
measure: Distribution of reasons for choosing the newly initiated AC treatment
timeFrame: Approximately 12 months
measure: Conditions of prescription of apixaban in NVAF patients
timeFrame: Approximately 12 months
measure: Proportion of AC-naive patients
timeFrame: Approximately 12 months
measure: Proportion of AC-experienced patients
timeFrame: Approximately 12 months
measure: Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics
timeFrame: Approximately 12 months
measure: Mean number of daily doses for prescribed apixaban treatment according to patient characteristics
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Fontaine Les Dijon
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: