AnticoagulationNCT02640222
APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in France.
Trial summary
The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- VKA, Apixaban and dabigatran
- How many people
- 321,501 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 31 Dec 2019
- 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: AC-naive and AC-experienced patients diagnosed with non-valvular AF, initiated with either apixaban, dabigatran, rivaroxaban or VKAs
Who may be able to join
- Patient meeting inclusion criteria of the French Système national d'information inter-régimes de l'assurance maladie (SNIIR-AM)/Programme de médicalisation des systèmes d'information (PMSI) claim databases (Patient insured by the French national health insurance general scheme stricto sensu (apart from local mutualist sections)
- Patients with at least one reimbursement of AC treatment (acenocoumarol, warfarine and fluidione for VKA treatments, apixaban, dabigatran or rivaroxaban for New oral anticoagulants (NOACs)) treatments during the inclusion period
- Patients initiated with a new AC treatment during the inclusion period, either AC naive or not
- Patients aged 18 or older at their first anticoagulant initiation during the inclusion period
- Patient diagnosed with non-valvular Atrial fibrillation (AF)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).
- Conditions
- Anticoagulation
- Being tested
- VKA, Apixaban, dabigatran, rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VKADrug
Also called Vitamin K antagonist
ApixabanDrug
dabigatranDrug
rivaroxabanDrug
| Study group | Role | What they receive |
|---|---|---|
| AC-naive treated with VKA | AC-naive treated with VKA Receives: Drug: VKA | |
| AC-naive treated with apixaban | AC-naive treated with apixaban Receives: Drug: Apixaban | |
| AC-naive treated with dabigatran | AC-naive treated with dabigatran Receives: Drug: dabigatran | |
| AC-naive treated with rivaroxaban | AC-naive treated with rivaroxaban Receives: Drug: rivaroxaban | |
| AC-experienced treated with VKA | AC-experienced treated with VKA Receives: Drug: VKA | |
| AC-experienced treated with apixaban | AC-experienced treated with apixaban Receives: Drug: Apixaban | |
| AC-experienced treated with dabigatran | AC-experienced treated with dabigatran Receives: Drug: dabigatran | |
| AC-experienced treated with rivaroxaban | AC-experienced treated with rivaroxaban Receives: Drug: rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Incidence rate (95%CI) of first event of stroke and/or systemic embolism (effectiveness) and of first event of major bleeding (safety) over the period of AC ex
Measured: Approximately 2 years
Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Time-to-first occurrence of stroke and/or systemic embolism (effectiveness) and of major bleedings (safety) using Kaplan-Meier product limit estimator (95%CI)
Measured: Approximately 2 years
Secondary outcomes (9)
Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment
- Risk of occurrence of a composite morbidity criterion: number of patients presenting at least 1 event during the exposure period, incidence rate, median time to occurrence of event in each subcohort, composite morbidity criterion being defined by stroke, systemic embolism or major bleeding, whichever occurs first.
- Risk of all-cause mortality: number of deaths during exposure period to studied AC treatment, incidence rate, median survival time
Measured: Approximately 2 years
Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI)
Measured: Approximately 2 years
Major characteristics of patients will be described by AC treatments
Major characteristics of patients and comorbidities were:
- proportion of AC-naive patients by AC treatment
- In each subcohort:
- Sociodemographic characteristics: median age, sex ratio, region of residence, CMU-C (Universal Health Coverage Complementary) beneficiary,
- NVAF characteristics : time since NVAF diagnosis,
- ALD status distribution (ALD Type, ICD-10 code for diagnosis),
- Past hospital stay : number and total length of hospital stays
- Previous exposure to AC treatment (class, molecule) over the 3 previous years, for AC-experienced patients.
- Thromboembolism risk factors: CHADS2 mean score, CHA2DS2 VASc mean score, and distribution according to the scores.
- Bleeding risk factors: modified HASBLED mean score and distribution according to the scores
- Charlson mean score and distribution according to the scores
Measured: Approximately 2 years
Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment
Treatment patterns at AC initiation: Type of the prescriber initiating the AC treatment (general practitioners, office-based cardiologists, hospital-based physicians and others), prescribed dosages, duration of initial prescription, co prescription (others AC, antiplatelet agents, NSAIDs, SRIs, strong inhibitors of both CYP3A4, anticonvulsivant strong inducer of hepatic enzymes, rifampicine, antiarrhythmic drugs)
Measured: Approximately 2 years
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator based on Adherence to treatment: mean Medication Possession Ratio (MPR), Persistence: number for AC treatment discontinuation, median time to discontinuation
Measured: Approximately 2 years
The healthcare resources utilization will be described by AC treatment
The healthcare resources utilization will be described by AC treatment based on number of medical visits, number of nurse acts, per category of act, number of drugs packages per therapeutic classes, number of biology and tests, per type of act, number of other explorations, number of hospital stays, number of sick leaves
Measured: Approximately 2 years
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments will be performed using:
- An analysis adjusted for confounding factors in order to verify adjustment quality and using:
- the Wald test from a logistic regression model for binary and other qualitative variables
- the F- test from a covariance analysis for quantitative variables
- An analysis after matching for confounding factors in order to verify matching quality and using:
- the Cochran-Mantel-Haenzel test for qualitative variables
- the F-test from a covariance analysis for quantitative variables
Measured: Approximately 2 years
Comparison of incidence rates of each studied event (stroke or systemic thromboembolic event, major bleeding, all-cause death) between apixaban and each of the other usual AC treatments
Measured: Approximately 2 years
Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
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
- Retrospective
- Enrolment
- 321,501 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
- NCT02640222
- Sponsor's protocol ID
- CV185-285
- Status last verified
- May 2022
- First submitted
- 22 Dec 2015
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. 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 SNIIRAM Study
- ClinicalTrials.gov ID
- NCT02640222
- Acronym / sponsor ID
- CV185-285
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321,501 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Dec 2015 (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 purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| AC-naive treated with VKA | – | Drug: VKAAC-naive treated with VKA |
| AC-naive treated with apixaban | – | Drug: ApixabanAC-naive treated with apixaban |
| AC-naive treated with dabigatran | – | Drug: dabigatranAC-naive treated with dabigatran |
| AC-naive treated with rivaroxaban | – | Drug: rivaroxabanAC-naive treated with rivaroxaban |
| AC-experienced treated with VKA | – | Drug: VKAAC-experienced treated with VKA |
| AC-experienced treated with apixaban | – | Drug: ApixabanAC-experienced treated with apixaban |
| AC-experienced treated with dabigatran | – | Drug: dabigatranAC-experienced treated with dabigatran |
| AC-experienced treated with rivaroxaban | – | Drug: rivaroxabanAC-experienced treated with rivaroxaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AC-naive and AC-experienced patients diagnosed with non-valvular AF, initiated with either apixaban, dabigatran, rivaroxaban or VKAs
Key inclusion criteria (5 listed)
- Patient meeting inclusion criteria of the French Système national d'information inter-régimes de l'assurance maladie (SNIIR-AM)/Programme de médicalisation des systèmes d'information (PMSI) claim databases (Patient insured by the French national health insurance general scheme stricto sensu (apart from local mutualist sections)
- Patients with at least one reimbursement of AC treatment (acenocoumarol, warfarine and fluidione for VKA treatments, apixaban, dabigatran or rivaroxaban for New oral anticoagulants (NOACs)) treatments during the inclusion period
- Patients initiated with a new AC treatment during the inclusion period, either AC naive or not
- Patients aged 18 or older at their first anticoagulant initiation during the inclusion period
- Patient diagnosed with non-valvular Atrial fibrillation (AF)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VKAAlso: Vitamin K antagonist | Drug | AC-experienced treated with VKA, AC-naive treated with VKA |
| Apixaban | Drug | AC-experienced treated with apixaban, AC-naive treated with apixaban |
| dabigatran | Drug | AC-experienced treated with dabigatran, AC-naive treated with dabigatran |
| rivaroxaban | Drug | AC-experienced treated with rivaroxaban, AC-naive treated with rivaroxaban |
Primary outcome
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
Time frame: Approximately 2 years
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Incidence rate (95%CI) of first event of stroke and/or systemic embolism (effectiveness) and of first event of major bleeding (safety) over the period of AC ex
Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator
Time frame: Approximately 2 years
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Time-to-first occurrence of stroke and/or systemic embolism (effectiveness) and of major bleedings (safety) using Kaplan-Meier product limit estimator (95%CI)
9 secondary outcomes
Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment
Time frame: Approximately 2 years
Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI)
Time frame: Approximately 2 years
Major characteristics of patients will be described by AC treatments
Time frame: Approximately 2 years
Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment
Time frame: Approximately 2 years
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator
Time frame: Approximately 2 years
The healthcare resources utilization will be described by AC treatment
Time frame: Approximately 2 years
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments
Time frame: Approximately 2 years
Comparison of incidence rates of each studied event (stroke or systemic thromboembolic event, major bleeding, all-cause death) between apixaban and each of the other usual AC treatments
Time frame: Approximately 2 years
Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments
Time frame: Approximately 2 years
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 18 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 5 inclusion and 0 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 18 May 2022. 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?
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure (time frame: Approximately 2 years). The study lists 2 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 18 May 2022.