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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Warfarin; Drug: Apixaban; Drug: Dabigatran; Drug: Rivaroxaban

• Registration Number: NCT02754154
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-31
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Primary Completion: 2018-12-26
• Study Completion: 2018-12-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients using Warfarin	Warfarin	Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin
Patients using Apixaban	Apixaban	Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban
Patients using Dabigatran	Dabigatran	Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran
Patients using Rivaroxaban	Rivaroxaban	Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban

Primary Outcome Measures

Name	Time	Method
Time to "First Major" Bleeding event	Up to 25 months

Secondary Outcome Measures

Name	Time	Method
Major Bleeding-Related Healthcare Utilization	Up to 25 months	(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event )
Major Bleeding-Related direct medical cost	Up to 25 months	(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)
Any Bleeding-Related direct medical cost	Up to 25 months	(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)
Time to "First Any" Bleeding event	Up to 25 months
Any Bleeding-Related Healthcare Utilization	Up to 25 months	(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event )