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

Active, not recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Dabigatran (Pradaxa)Drug
    ARM 1: Kind: Experimental
    Label: AC-naive treated with dabigatran
    Description: AC-naive treated with dabigatran
    ARM 2: Kind: Experimental
    Label: AC-experienced treated with dabigatran
    Description: AC-experienced treated with dabigatran
  • Rivaroxaban Drug
    ARM 1: Kind: Experimental
    Label: AC-naive treated with rivaroxaban
    Description: AC-naive treated with rivaroxaban
    ARM 2: Kind: Experimental
    Label: AC-experienced treated with rivaroxaban
    Description: AC-experienced treated with rivaroxaban
  • Apixaban Drug
    Other Names: BMS-562247
    ARM 1: Kind: Experimental
    Label: AC-naive treated with apixaban
    Description: AC-naive treated with apixaban
    ARM 2: Kind: Experimental
    Label: AC-experienced treated with apixaban
    Description: AC-experienced treated with apixaban
  • VKA Drug
    Other Names: Vitamin K antagonist
    ARM 1: Kind: Experimental
    Label: AC-naive treated with VKA
    Description: AC-naive treated with VKA
    ARM 2: Kind: Experimental
    Label: AC-experienced treated with VKA
    Description: AC-experienced treated with VKA

Trial Design

  • Observation: Cohort
  • Perspective: Retrospective
  • Sampling: Non-Probability Sample

Trial Population

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure Approximately 2 years Yes
Primary Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator Approximately 2 years Yes
Secondary Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment Approximately 2 years Yes
Secondary Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI) Approximately 2 years Yes
Secondary Major characteristics of patients will be described by AC treatments Approximately 2 years Yes
Secondary Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment Approximately 2 years Yes
Secondary Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator Approximately 2 years Yes
Secondary The healthcare resources utilization will be described by AC treatment Approximately 2 years Yes
Secondary Comparisons of major characteristics of patients between apixaban and each of the other AC treatments Approximately 2 years Yes
Secondary 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 Approximately 2 years Yes
Secondary Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments Approximately 2 years Yes

Sponsors