An observational study in Anticoagulation, sponsored by Bristol-Myers Squibb. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Bristol-Myers Squibb · Observational
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?
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 2,081 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
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Cardiologists in france caring AF patients
Exclusion Criteria:
Patient characteristics in NVAF patients initiating a new AC-treatment
Patient's characteristics: age, gender, weight and height, BMI, dependence status
Time frame: Approximately 12 months
Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients
Time frame: Approximately 12 months
Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients
Time frame: 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
Time frame: Approximately 12 months
Comparing disease characteristics between apixaban and other NOACs in AC-naive patients
Time frame: Approximately 12 months
Comparing disease characteristics between apixaban and VKAs in AC-naive patients
Time frame: 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
Time frame: Approximately 12 months
Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients
Time frame: Approximately 12 months
Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients
Time frame: 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
Time frame: Approximately 12 months
Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients
Time frame: Approximately 12 months
Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients
Time frame: Approximately 12 months
Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)
Time frame: 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
Time frame: Approximately 12 months
Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)
Time frame: Approximately 12 months
Distribution of reasons for initiating a new AC treatment
Time frame: 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
Time frame: 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
Time frame: Approximately 12 months
Proportion of AC-naive patients
Time frame: Approximately 12 months
Proportion of AC-experienced patients
Time frame: Approximately 12 months
Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics
Time frame: Approximately 12 months
Mean number of daily doses for prescribed apixaban treatment according to patient characteristics
Time frame: Approximately 12 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb