ClinicalTrials.gg
CompletedNCT01885585Updated Feb 8, 2016

Eliquis Regulatory Post Marketing Surveillance (rPMS)

An observational study in Venous Thromboembolism, sponsored by Bristol-Myers Squibb. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-02-08.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
19 Years and older
Sex
All
01

Study summary

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice

02

Conditions studied

  • Venous Thromboembolism
03

In context

Venous Thromboembolism

708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.

This study's enrollment of 100 is below the median of 630 across 289 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism 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.

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

04

Who can participate

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

Study population

Primary care clinic Patients must be ≥19 years of age, at risk for venous thrombosis, and have elected to undergo total hip replacement arthroplasty or total knee replacement arthroplasty will be included in this study

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

  • Signed data release
  • Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Being treated for an indication not approved for the use of Eliquis® in Korea
  • Is contraindicated for the use of Eliquis® as described in the Korean label
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with risk of VTE

    Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release

    Drug: Apixaban

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Adverse Events (AEs) and serious AEs

    Time frame: Up to 30 days after last study drug dose

07

Study locations

1 site
  • Local Institution
    Seoul, 110-744, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

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

Registered
Jun 21, 2013
First posted
Jun 25, 2013
Start
Jul 2014
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
Feb 8, 2016
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 Feb 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01885585
Responsible party
Sponsor
First posted
Jun 25, 2013
Start date
Jul 2014
Primary completion
May 2015
Completion
May 2015
Last update
Feb 8, 2016

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 Feb 2016. 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.

Sign in to follow

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.

Start the discussion