ClinicalTrials.gg
CompletedNCT03474757TRENDUpdated Oct 6, 2020

Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by Bayer · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,528
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
22nd of 51
10,528 · median 3,055
Started
2018
with 3 others
Observational
51 of 64
none open now
Registered
48th of 64
by date

Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 22nd largest by enrollment of the 51 observational ones that give a count, is one of 4 that started in 2018, is one of 51 observational ones, and was the 48th 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 · no healthy volunteers.

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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

This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia

03

Conditions studied

  • Atrial Fibrillation

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Using the population from the Audifarma database, the study will be comprised of three separate cohorts of first time users of rivaroxaban, dabigatran and apixaban using the first prescription date (index date) of the respective drug (index drug). All patients aged ≥18 years with at least one year of enrollment in the databases and one year since first encounter with healthcare provider will be included in the 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

  • First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting.
  • Non valvular Atrial Fibrillation (NVAF) Patients
  • aged ≥18 years
  • at least one year of enrollment in the Audifarma database
  • one year since first encounter with healthcare provider will be included in the study

Exclusion criteria

Exclusion Criteria:

  • Patients with any record of index drug prescription prior to the enrolment period.
  • Patients who qualify as members of more than one cohort study on the same day
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,528 participants (actual)
Patient registry
No

Groups and cohorts

  • SPAF patients in Colombia_Rivaroxaban

    First time users of rivaroxaban in the Audifarma database

    Other: Data Collection

  • SPAF patients in Colombia_Dabigatran

    First time users of dabigatran in the Audifarma database

    Other: Data Collection

  • SPAF patients in Colombia_Apixaban

    First time users of apixaban in the Audifarma database

    Other: Data Collection

Interventions

  • OtherData Collection

    Data will be extracted from July 2009 to the last available database extraction

06

What researchers measure

Primary outcomes

  1. Age

    Time frame: At Baseline

  2. Sex

    Time frame: At Baseline

  3. Co-morbidity

    Time frame: At Baseline

  4. Healthcare utilization

    Primary Care Physicians visits, Outpatient visits and Hospital admissions

    Time frame: Up to 2 years

  5. Proportion of Naive to non-naive patient

    Time frame: At Baseline

  6. Dose at first prescription

    Time frame: Up to 6 years

  7. Duration of treatment

    Time frame: Up to 6 years

  8. Discontinuation

    Time frame: Up to 6 years

  9. Switch to another study drug

    Time frame: Up to 6 years

Secondary outcomes

  1. Time trends of usage of study medications

    Time frame: Up to 6 years

07

Study locations

1 site
  • Many Locations
    Multiple Locations, Colombia
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jul 2018, 5 months.

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

Registered
Mar 9, 2018
First posted
Mar 23, 2018
StartActual
Feb 28, 2018
Primary completionActual
Jul 30, 2018
CompletionActual
Jul 30, 2018
Last update
Oct 6, 2020
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 Oct 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03474757
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Feb 28, 2018
Primary completion
Jul 30, 2018
Completion
Jul 30, 2018
Last update
Oct 6, 2020

Oversight

Data monitoring committee
No
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 Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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