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OpenTrials
Completed

NCT Number: NCT02714855

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

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?

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Fontaine-lès-Dijon, 21121, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Primary outcomes

  1. Patient characteristics in NVAF patients initiating a new AC-treatment

    Time frame: Approximately 12 months

    Patient's characteristics: age, gender, weight and height, BMI, dependence status

  2. Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients

    Time frame: Approximately 12 months

  3. Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients

    Time frame: Approximately 12 months

  4. Disease characteristics in NVAF patients initiating a new AC-treatment

    Time frame: 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

  5. Comparing disease characteristics between apixaban and other NOACs in AC-naive patients

    Time frame: Approximately 12 months

  6. Comparing disease characteristics between apixaban and VKAs in AC-naive patients

    Time frame: Approximately 12 months

  7. Comorbidities in NVAF patients initiating a new AC-treatment

    Time frame: 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

  8. Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients

    Time frame: Approximately 12 months

  9. Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients

    Time frame: Approximately 12 months

  10. Treatment history in NVAF patients initiating a new AC-treatment

    Time frame: 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

  11. Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients

    Time frame: Approximately 12 months

  12. Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients

    Time frame: Approximately 12 months

Secondary outcomes

  1. Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)

    Time frame: Approximately 12 months

  2. Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment

    Time frame: 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

  3. Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)

    Time frame: Approximately 12 months

  4. Distribution of reasons for initiating a new AC treatment

    Time frame: Approximately 12 months

  5. Distribution of reasons for choosing the newly initiated AC treatment

    Time frame: 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

  6. Conditions of prescription of apixaban in NVAF patients

    Time frame: Approximately 12 months

    Condition of prescription of apixaban:

    Daily dosage (mg) at apixaban initiation, number of doses per day at apixaban initiation

  7. Proportion of AC-naive patients

    Time frame: Approximately 12 months

  8. Proportion of AC-experienced patients

    Time frame: Approximately 12 months

  9. Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics

    Time frame: Approximately 12 months

  10. Mean number of daily doses for prescribed apixaban treatment according to patient characteristics

    Time frame: Approximately 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 22, 2016
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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