Overview

This trial is active, not recruiting.

Condition anticoagulation
Treatments vka, apixaban, dabigatran, rivaroxaban
Sponsor Bristol-Myers Squibb
Start date June 2013
End date December 2016
Trial size 18000 participants
Trial identifier NCT02640222, CV185-285

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
AC-naive treated with VKA
vka Vitamin K antagonist
AC-naive treated with apixaban
apixaban
AC-naive treated with dabigatran
dabigatran
AC-naive treated with rivaroxaban
rivaroxaban
AC-experienced treated with VKA
vka Vitamin K antagonist
AC-experienced treated with apixaban
apixaban
AC-experienced treated with dabigatran
dabigatran
AC-experienced treated with rivaroxaban
rivaroxaban

Primary Outcomes

Measure
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
time frame: 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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.