Overview

Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France

Status:
Completed
Trial end date:
2018-09-30
Target enrollment:
0
Participant gender:
All
Summary
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
Janssen Scientific Affairs, LLC
Treatments:
Dabigatran
Rivaroxaban
Vitamin K
Vitamins
Criteria
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