Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France

Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study

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?

Study Overview

• Status: Completed
• Conditions: Anticoagulation
• Intervention / Treatment: Drug: Apixaban

• Study Type: Observational
• Enrollment (Actual): 2081

Contacts and Locations

Study Locations

• France
  • Fontaine Les Dijon, France, 21121
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardiologists in france caring AF patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics in NVAF patients initiating a new AC-treatment	Patient's characteristics: age, gender, weight and height, BMI, dependence status	Approximately 12 months
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	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	Approximately 12 months
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	Comorbidities: congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding	Approximately 12 months
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	Treatment history: Previous AC strategy (no treatment, apixaban, other NOAC, VKAs) , Duration with previous AC strategy and indication of previous AC treatment	Approximately 12 months
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

Outcome Measure	Measure Description	Time Frame
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	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	Approximately 12 months
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	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	Approximately 12 months
Conditions of prescription of apixaban in NVAF patients	Condition of prescription of apixaban: Daily dosage (mg) at apixaban initiation, number of doses per day at apixaban initiation	Approximately 12 months
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: CV185-345