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

Anticoagulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714855
• Other study ID #: CV185-345
• Status: Completed
• Phase: N/A
• First received: March 16, 2016
• Last updated: April 17, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2081
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation
• Embolism

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
France	Local Institution	Fontaine Les Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics in NVAF patients initiating a new AC-treatment	Patient's characteristics: age, gender, weight and height, BMI, dependence status	Approximately 12 months
Primary	Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients		Approximately 12 months
Primary	Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients		Approximately 12 months
Primary	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
Primary	Comparing disease characteristics between apixaban and other NOACs in AC-naive patients		Approximately 12 months
Primary	Comparing disease characteristics between apixaban and VKAs in AC-naive patients		Approximately 12 months
Primary	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
Primary	Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients		Approximately 12 months
Primary	Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients		Approximately 12 months
Primary	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
Primary	Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients		Approximately 12 months
Primary	Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients		Approximately 12 months
Secondary	Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)		Approximately 12 months
Secondary	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
Secondary	Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)		Approximately 12 months
Secondary	Distribution of reasons for initiating a new AC treatment		Approximately 12 months
Secondary	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
Secondary	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
Secondary	Proportion of AC-naive patients		Approximately 12 months
Secondary	Proportion of AC-experienced patients		Approximately 12 months
Secondary	Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics		Approximately 12 months
Secondary	Mean number of daily doses for prescribed apixaban treatment according to patient characteristics		Approximately 12 months

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