Clinical trial NCT02640222: APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study
Official title: APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-12-28
Enrollment: 321501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
timeFrame: Approximately 2 years
measure: Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator
timeFrame: 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
timeFrame: Approximately 2 years
measure: Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI)
timeFrame: Approximately 2 years
measure: Major characteristics of patients will be described by AC treatments
timeFrame: Approximately 2 years
measure: Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment
timeFrame: Approximately 2 years
measure: Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator
timeFrame: Approximately 2 years
measure: The healthcare resources utilization will be described by AC treatment
timeFrame: Approximately 2 years
measure: Comparisons of major characteristics of patients between apixaban and each of the other AC treatments
timeFrame: Approximately 2 years
measure: 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
timeFrame: Approximately 2 years
measure: Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Rueil-malmaison Cedex
country: France
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: