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

May 4, 2022 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

321182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral anticoagulants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients using Warfarin
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin
Drug: Warfarin
Patients using Apixaban
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban
Drug: Apixaban
Patients using Dabigatran
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran
Drug: Dabigatran
Patients using Rivaroxaban
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban
Drug: Rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to "First Major" Bleeding event
Time Frame: Up to 25 months
Up to 25 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to "First Any" Bleeding event
Time Frame: Up to 25 months
Up to 25 months
Major Bleeding-Related Healthcare Utilization
Time Frame: 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 )
Up to 25 months
Any Bleeding-Related Healthcare Utilization
Time Frame: 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 )
Up to 25 months
Major Bleeding-Related direct medical cost
Time Frame: Up to 25 months
(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)
Up to 25 months
Any Bleeding-Related direct medical cost
Time Frame: Up to 25 months
(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)
Up to 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2014

Primary Completion (Actual)

December 26, 2018

Study Completion (Actual)

December 26, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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