Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments warfarin, apixaban, dabigatran, rivaroxaban
Sponsor Bristol-Myers Squibb
Start date December 2014
End date June 2017
Trial size 88983 participants
Trial identifier NCT02754154, CV185-433

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin
warfarin
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban
apixaban
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran
dabigatran
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban
rivaroxaban

Primary Outcomes

Measure
Time to "First Major" Bleeding event
time frame: Up to 25 months

Secondary Outcomes

Measure
Time to "First Any" Bleeding event
time frame: Up to 25 months
Major Bleeding-Related Healthcare Utilization
time frame: Up to 25 months
Any Bleeding-Related Healthcare Utilization
time frame: Up to 25 months
Major Bleeding-Related direct medical cost
time frame: Up to 25 months
Any Bleeding-Related direct medical cost
time frame: Up to 25 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.