Study Completed

Stroke Prevention in Atrial Fibrillation

Bayer Identifier:

18032

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

EGBoX (Study of Xarelto Using French Claims Data,EGB)

Trial purpose

The primary objective of the study is to identify patients treated by Xarelto
for SP-AF (Stroke Prevention in Atrial Fibrillation), the “joint population,,
and to describe the characteristics of Xarelto users and the conditions of use
in this cohort using a sample from a French healthcare database.
Conditions of use will describe patterns of use, potential inadequate use of
the drug, adherence to the drug with the description of the implementation
(defined as the extent to which a patient's actual dosing corresponds to the
prescribed dosing regimen, from initiation until the last dose is taken) and
the persistence which represents the length of time between initiation and
last dose.
The secondary objectives of the study include the identification of both a
VKA and a Pradaxa® treated cohort for SP-AF with, respectively, VKA or
Pradaxa;
The secondary objectives are : the description of subject characteristics
(demographics, type of prescriber, CHADS2 and CHA2DS2-VASC scores -
comorbid conditions (or comorbidities)) in these cohorts; the description of
implementation for Pradaxa® cohort and persistence for VKA and Pradaxa®
cohorts ; the description of Medical Resources Utilisation (MRU) for all
cohorts; Pre-specified descriptive analysis of effectiveness (stroke,
myocardial infarction and overall mortality) and safety (bleeding, overall
mortality) outcomes for all cohorts. These secondary analyses should be
viewed as exploratory descriptive analyses for potential future comparative
effectiveness research of anticoagulants in SP-AF using French claims data.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal

6184

Trial Dates

April 2015 - March 2016

Phase

Phase 4

Could I Receive a placebo

N/A

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed		many locations, France

Primary Outcome

Treatment exposure
Safety Issue:
No
Baseline variables (Demographics, type of prescriber, comorbid conditions and risk factors, coprescriptions)
Safety Issue:
No
Potential inadequate use
Safety Issue:
No
Patterns of use of the drug: 1st line or 2nd line initiation, switch, discontinuation, resumption
Safety Issue:
No
Adherence: Implementation and persistence
Safety Issue:
No

Secondary Outcome

Exposure (cohorts Pradaxa® and VKA populations)
Safety Issue:
No
Subject characteristics (Cohorts Pradaxa® and VKA populations)
Safety Issue:
No
Baseline variables: Demographics, type of prescriber, comorbid conditions and risk factors, coprescriptions ; (Cohorts Pradaxa® and VKA populations)
Safety Issue:
No
Adherence: Implementation (cohort Pradaxa® population) and persistence (cohorts Pradaxa® and VKA populations)
Safety Issue:
No
Medical Resource Utilization (cohorts Xarelto®, Pradaxa® and VKA populations)
Safety Issue:
No
Effectiveness outcomes: Ischemic stroke, myocardial infarction, overall mortality (cohorts Xarelto®, Pradaxa® and VKA populations)
Safety Issue:
No
Safety outcomes: Major bleeding, overall mortality (cohorts Xarelto, Pradaxa and VKA populations)
Safety Issue:
Yes

Trial design

XAFRAN (Xarelto® A FRench ANalysis of claims database)

Trial Type

Observational

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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