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Completed

NCT Number: NCT02640222

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

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rueil-Malmaison, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VKA

Drug

Other names: Vitamin K antagonist

Apixaban

Drug

dabigatran

Drug

Rivaroxaban

Drug

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI)

    Time frame: Approximately 2 years

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Dec 28, 2015
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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