NCT02754154

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321,182

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
Last Updated

May 9, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

April 26, 2016

Last Update Submit

May 4, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time to "First Major" Bleeding event

    Up to 25 months

Secondary Outcomes (5)

  • Time to "First Any" Bleeding event

    Up to 25 months

  • Major Bleeding-Related Healthcare Utilization

    Up to 25 months

  • Any Bleeding-Related Healthcare Utilization

    Up to 25 months

  • Major Bleeding-Related direct medical cost

    Up to 25 months

  • Any Bleeding-Related direct medical cost

    Up to 25 months

Study Arms (4)

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

Interventions

WarfarinDRUG
Patients using Warfarin
ApixabanDRUG
Patients using Apixaban
DabigatranDRUG
Patients using Dabigatran
RivaroxabanDRUG
Patients using Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

WarfarinapixabanDabigatranRivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyridinesBenzimidazolesThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 28, 2016

Study Start

December 31, 2014

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

May 9, 2022

Record last verified: 2022-04