NCT02640222

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321,501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

December 22, 2015

Last Update Submit

May 16, 2022

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (2)

  • Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure

    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

    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 Outcomes (9)

  • 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

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

    Approximately 2 years

  • Major characteristics of patients will be described by AC treatments

    Approximately 2 years

  • Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment

    Approximately 2 years

  • Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator

    Approximately 2 years

  • +4 more secondary outcomes

Study Arms (8)

AC-naive treated with VKA

AC-naive treated with VKA

Drug: VKA

AC-naive treated with apixaban

AC-naive treated with apixaban

Drug: Apixaban

AC-naive treated with dabigatran

AC-naive treated with dabigatran

Drug: dabigatran

AC-naive treated with rivaroxaban

AC-naive treated with rivaroxaban

Drug: rivaroxaban

AC-experienced treated with VKA

AC-experienced treated with VKA

Drug: VKA

AC-experienced treated with apixaban

AC-experienced treated with apixaban

Drug: Apixaban

AC-experienced treated with dabigatran

AC-experienced treated with dabigatran

Drug: dabigatran

AC-experienced treated with rivaroxaban

AC-experienced treated with rivaroxaban

Drug: rivaroxaban

Interventions

VKADRUG
Also known as: Vitamin K antagonist
AC-experienced treated with VKAAC-naive treated with VKA
ApixabanDRUG
AC-experienced treated with apixabanAC-naive treated with apixaban
dabigatranDRUG
AC-experienced treated with dabigatranAC-naive treated with dabigatran
rivaroxabanDRUG
AC-experienced treated with rivaroxabanAC-naive treated with rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient diagnosed with non-valvular Atrial fibrillation (AF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rueil-Malmaison, France

Location

Related Links

MeSH Terms

Interventions

acarboxyprothrombinapixabanDabigatranRivaroxaban

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 28, 2015

Study Start

January 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2019

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

FR(1)