ClinicalTrials.gg
CompletedNCT03462446Updated Mar 12, 2018

Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.

Sponsored by Bayer · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
249
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 64 studies in Atrial Fibrillation by Bayer — 1 open to participants now, 1 under way, none of them phase 3. Atrial Fibrillation · Bayer.

Enrollment
42nd of 51
249 · median 3,055
Started
2015
with 9 others
Observational
51 of 64
none open now
Registered
47th of 64
by date

Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 42nd largest by enrollment of the 51 observational ones that give a count, is one of 10 that started in 2015, is one of 51 observational ones, and was the 47th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

1 of the 64 studies in Atrial Fibrillation by Bayer is open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 64 studies in Atrial Fibrillation by Bayer, or all of them as a file.
02

Study summary

The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.

03

Conditions studied

  • Atrial Fibrillation

Keywords

  • Atrial fibrillation
  • VKA
  • Stroke
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.

Inclusion criteria

  • Older than 18 years
  • Diagnosis of non-valvular AF (ICD code 427.31)
  • Pharmacological treatment with VKAs or rivaroxaban following diagnosis

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
249 participants (actual)
Patient registry
No

Groups and cohorts

  • Treatment group with Rivaroxaban

    Patients treated with Rivaroxaban

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

  • Control group with VKAs

    Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%).

    Drug: Vitamin K antagonists (VKAs)

Interventions

  • As prescribed by treating physicians

  • DrugVitamin K antagonists (VKAs)

    As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

06

What researchers measure

Primary outcomes

  1. Time in therapeutic range (TTR) values in the last 6 months

    Time frame: 6 months

  2. Presence of stroke

    Presence of stroke prior and subsequent to treatment

    Time frame: 12 months

  3. Active substance received

    Rivaroxaban or VKAs (Acenocoumarol and Warfarin)

    Time frame: 12 months

Secondary outcomes

  1. Date of stroke

    Time frame: 12 months

  2. Type of stroke

    Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.

    Time frame: 12 months

  3. Duration of treatment (in days)

    Time frame: 12 months

  4. Dose of the prescribed treatment

    Time frame: 12 months

  5. Frequency of the prescribed treatment (in hours)

    Time frame: 12 months

Other outcomes

  1. Date of AF diagnosis

    Time frame: 12 months

  2. Comorbidities

    Time frame: 12 months

07

Study locations

1 site
  • Granada, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2015 to primary completion in May 2016, 11 months.

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

Registered
Feb 26, 2018
First posted
Mar 12, 2018
StartActual
Jun 1, 2015
Primary completionActual
May 1, 2016
CompletionActual
May 1, 2016
Last update
Mar 12, 2018
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 Mar 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03462446
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 12, 2018
Start date
Jun 1, 2015
Primary completion
May 1, 2016
Completion
May 1, 2016
Last update
Mar 12, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. 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