Trial Condition(s):

Stroke Prevention in Atrial Fibrillation

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

Bayer Identifier:

18032

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
6184
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
N/A

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

many locations, France

Status
Completed
 

Trial Design