CompletedNCT02687854PIXI-FUpdated Apr 5, 2017

Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-05.

Study summary

To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.

Conditions studied

Atrial Fibrillation

Browse trials for

Keywords

Non-valvular atrial fibrillation (NVAF)
Prevention
Stroke

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 18,591 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

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

Who can participate

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

Study population

Patients with non-valvular atrial fibrillation (NVAF)

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

NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score ≥2 during the 180 days prior to index apixaban use baseline period

Exclusion criteria

Exclusion Criteria:

Patients \<18 years of age
Patients with valvular AF (Atrial fibrillation)
Pregnancy
Malignant cancers
Transient cause of AF
Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))
Patients with major surgery defined as hip or knee replacement
Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
Prescription of more than one OAC on the index date
Patient with any of the events defined in the composite endpoint

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 18,591 participants (actual)

Groups and cohorts

Apixaban
Non-valvular atrial fibrillation patients who were initiated on apixaban for stroke prevention
Drug: Apixaban
Vitamin K antagonist
Non-valvular atrial fibrillation patients who were initiated on Vitamin K antagonist for stroke prevention
Drug: Vitamin K antagonist

Interventions

DrugApixaban
As prescribed by treating physicians
DrugVitamin K antagonist
As prescribed by treating physicians

What researchers measure

Primary outcomes

Incidence of Hospitalization Events (composite endpoint)
Time frame: Up to 2 years

Study locations

1 site

New York, New York, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2016 to primary completion in Mar 2016, 0 months.

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

Registered: Feb 17, 2016
First posted: Feb 22, 2016
StartActual: Feb 12, 2016
Primary completionActual: Mar 1, 2016
CompletionActual: Mar 1, 2016
Last update: Apr 5, 2017

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 Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02687854
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Feb 22, 2016
Start date: Feb 12, 2016
Primary completion: Mar 1, 2016
Completion: Mar 1, 2016
Last update: Apr 5, 2017

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrial Fibrillation →

Other studies from this sponsor

Bayer →

Start the discussion