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CompletedNCT02754154Updated May 9, 2022

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

An observational study in Atrial Fibrillation, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
321,182
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 321,182 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
321,182 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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

    (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 )

    Time frame: Up to 25 months

  3. Any Bleeding-Related Healthcare Utilization

    (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 )

    Time frame: Up to 25 months

  4. Major Bleeding-Related direct medical cost

    (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)

    Time frame: Up to 25 months

  5. Any Bleeding-Related direct medical cost

    (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)

    Time frame: Up to 25 months

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2014 to primary completion in Dec 2018, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2016
First posted
Apr 28, 2016
StartActual
Dec 31, 2014
Primary completionActual
Dec 26, 2018
CompletionActual
Dec 26, 2018
Last update
May 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02754154
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 28, 2016
Start date
Dec 31, 2014
Primary completion
Dec 26, 2018
Completion
Dec 26, 2018
Last update
May 9, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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