Trial Condition(s):

Atrial Fibrillation

Benefit-Risk Of arterial THrombotic prEvention with Rivaroxaban for atrial fibrillation in France (BROTHER)

Bayer Identifier:

18656

ClinicalTrials.gov Identifier:

NCT02864758

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial
fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran

Inclusion Criteria
- Definite non-valvular atrial fibrillation:
 -  A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
 − No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
 − Definite AF information in the database
Probable non-valvular atrial fibrillation:-
 − A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
 − No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
 − Probable AF information in the database (using the development of an AF disease score, see variables definition below),
Exclusion Criteria
- Patients with Rheumatic valve disease
 - Patients with valve replacement
 - Patients treated with anticoagulants for venous  
 - thromboemboslim or prevention of venous   
 - thromboembolism after orthopedic surgery

Trial Summary

Enrollment Goal
99999
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Recruiting
 

Trial Design