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

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ClinicalTrials.gov Identifier: NCT02714855
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Anticoagulation Drug: Apixaban

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Study Type : Observational
Actual Enrollment : 2081 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : October 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiologists in france caring AF patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714855


Locations
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France
Local Institution
Fontaine Les Dijon, France, 21121
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02714855    
Other Study ID Numbers: CV185-345
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Atrial Fibrillation
Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants