Overview

Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Status:
Unknown status
Trial end date:
2019-02-26
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Anticoagulants
Apixaban
Dabigatran
Rivaroxaban
Warfarin
Criteria
Inclusion Criteria:

- Patients ≥18 years old as of the index date

- At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index
date, identified by any medical claim

- At least one year of baseline period and continuous enrollment for at least 12 months
prior to index date Individuals with NVAF who were using oral anticoagulants (i.e.,
warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan
1, 2012 through December 31, 2013 or last date of the last data cut available at the
time of execution of the study

Exclusion Criteria:

- Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral
stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the
baseline period any time prior to or on index date

- Patients with any evidence of pregnancy at any time during the baseline will be
excluded