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
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site many locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
3
Primary Outcome
- Treatment exposureTimeframe:
- Baseline variables (Demographics, type of prescriber, comorbid conditions and risk factors, coprescriptions)Timeframe:
- Potential inadequate useTimeframe:
- Patterns of use of the drug: 1st line or 2nd line initiation, switch, discontinuation, resumptionTimeframe:
- Adherence: Implementation and persistenceTimeframe:
Secondary Outcome
- Exposure (cohorts Pradaxa® and VKA populations)Timeframe:
- Subject characteristics (Cohorts Pradaxa® and VKA populations)Timeframe:
- Baseline variables: Demographics, type of prescriber, comorbid conditions and risk factors, coprescriptions ; (Cohorts Pradaxa® and VKA populations)Timeframe:
- Adherence: Implementation (cohort Pradaxa® population) and persistence (cohorts Pradaxa® and VKA populations)Timeframe:
- Medical Resource Utilization (cohorts Xarelto®, Pradaxa® and VKA populations)Timeframe:
- Effectiveness outcomes: Ischemic stroke, myocardial infarction, overall mortality (cohorts Xarelto®, Pradaxa® and VKA populations)Timeframe:
- Safety outcomes: Major bleeding, overall mortality (cohorts Xarelto, Pradaxa and VKA populations)Timeframe:
Additional Information
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