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

May 16, 2022 updated by: Bristol-Myers Squibb
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rueil-malmaison Cedex, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AC-naive and AC-experienced patients diagnosed with non-valvular AF, initiated with either apixaban, dabigatran, rivaroxaban or VKAs

Description

Inclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
AC-naive treated with VKA
Drug: VKA
Other Names:
  • Vitamin K antagonist
AC-naive treated with apixaban
Drug: Apixaban
AC-naive treated with dabigatran
Drug: dabigatran
AC-naive treated with rivaroxaban
Drug: rivaroxaban
AC-experienced treated with VKA
Drug: VKA
Other Names:
  • Vitamin K antagonist
AC-experienced treated with apixaban
Drug: Apixaban
AC-experienced treated with dabigatran
Drug: dabigatran
AC-experienced treated with rivaroxaban
Drug: rivaroxaban

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Approximately 2 years
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)
Approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
  • 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
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
Approximately 2 years
Major characteristics of patients will be described by AC treatments
Time Frame: Approximately 2 years

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
Approximately 2 years
Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment
Time Frame: Approximately 2 years
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)
Approximately 2 years
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator
Time Frame: Approximately 2 years
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
Approximately 2 years
The healthcare resources utilization will be described by AC treatment
Time Frame: Approximately 2 years
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
Approximately 2 years
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments
Time Frame: Approximately 2 years

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
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
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
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV185-285

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