AnticoagulationNCT02714855
Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- Apixaban
- How many people
- 2,081 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiologists in france caring AF patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read more
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?
- Conditions
- Anticoagulation
- Being tested
- Apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics in NVAF patients initiating a new AC-treatment
Patient's characteristics: age, gender, weight and height, BMI, dependence status
Measured: Approximately 12 months
Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients
Measured: Approximately 12 months
Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients
Measured: 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
Measured: Approximately 12 months
Comparing disease characteristics between apixaban and other NOACs in AC-naive patients
Measured: Approximately 12 months
Comparing disease characteristics between apixaban and VKAs in AC-naive patients
Measured: 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
Measured: Approximately 12 months
Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients
Measured: Approximately 12 months
Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients
Measured: 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
Measured: Approximately 12 months
Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients
Measured: Approximately 12 months
Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients
Measured: Approximately 12 months
Secondary outcomes (10)
Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)
Measured: 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
Measured: Approximately 12 months
Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)
Measured: Approximately 12 months
Distribution of reasons for initiating a new AC treatment
Measured: 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
Measured: 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
Measured: Approximately 12 months
Proportion of AC-naive patients
Measured: Approximately 12 months
Proportion of AC-experienced patients
Measured: Approximately 12 months
Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics
Measured: Approximately 12 months
Mean number of daily doses for prescribed apixaban treatment according to patient characteristics
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714855
- Sponsor's protocol ID
- CV185-345
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02714855
- Acronym / sponsor ID
- CV185-345
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,081 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiologists in france caring AF patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban | Drug | – |
Primary outcome
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
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
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
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
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
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
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
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
10 secondary outcomes
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
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
Time frame: Approximately 12 months
Conditions of prescription of apixaban in NVAF patients
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient characteristics in NVAF patients initiating a new AC-treatment (time frame: Approximately 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.