Skip to main content
OpenTrials
Completed

NCT Number: NCT02754154

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

Apixaban

Drug

dabigatran

Drug

Rivaroxaban

Drug

Primary outcomes

  1. Time to "First Major" Bleeding event

    Time frame: Up to 25 months

Secondary outcomes

  1. Time to "First Any" Bleeding event

    Time frame: Up to 25 months

  2. 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 )

  3. 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 )

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.