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

An observational study of Atrial Fibrillation, run by Bayer at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Data Collection
How many people: 10,528 participants
Where: 1 siteColombia
Study dates: 28 Feb 2018to 30 Jul 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Many Locations
Multiple Locations

Other trials in Colombia

About this study

Official title: Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia

Conditions: Atrial Fibrillation
Being tested: Data Collection
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03474757
Study group	Role	What they receive
SPAF patients in Colombia_Rivaroxaban		First time users of rivaroxaban in the Audifarma database Receives: Other: Data Collection
SPAF patients in Colombia_Dabigatran		First time users of dabigatran in the Audifarma database Receives: Other: Data Collection
SPAF patients in Colombia_Apixaban		First time users of apixaban in the Audifarma database Receives: Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Age
Measured: At Baseline
Sex
Measured: At Baseline
Co-morbidity
Measured: At Baseline
Healthcare utilization
Primary Care Physicians visits, Outpatient visits and Hospital admissions
Measured: Up to 2 years
Proportion of Naive to non-naive patient
Measured: At Baseline
Dose at first prescription
Measured: Up to 6 years
Duration of treatment
Measured: Up to 6 years
Discontinuation
Measured: Up to 6 years
Switch to another study drug
Measured: Up to 6 years

Secondary outcomes (1)

Time trends of usage of study medications
Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201830 Jul 2018

First posted23 Mar 2018
Study start28 Feb 2018
Primary completion30 Jul 2018
Study completion30 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 10,528 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03474757
Sponsor's protocol ID: 20104
Acronym: TREND
Status last verified: Oct 2020
First submitted: 9 Mar 2018
Last updated: 6 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia
ClinicalTrials.gov ID: NCT03474757
Acronym / sponsor ID: TREND / 20104
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 10,528 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Collaborators: Janssen Research & Development, LLC
Study start: 28 Feb 2018 (actual)
Primary completion: 30 Jul 2018 (actual)
Study completion: 30 Jul 2018 (actual)
First posted: 23 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
SPAF patients in Colombia_Rivaroxaban	–	Other: Data CollectionFirst time users of rivaroxaban in the Audifarma database
SPAF patients in Colombia_Dabigatran	–	Other: Data CollectionFirst time users of dabigatran in the Audifarma database
SPAF patients in Colombia_Apixaban	–	Other: Data CollectionFirst time users of apixaban in the Audifarma database

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Data CollectionData will be extracted from July 2009 to the last available database extraction	Other	SPAF patients in Colombia_Apixaban, SPAF patients in Colombia_Dabigatran, SPAF patients in Colombia_Rivaroxaban

Primary outcome

Age
Time frame: At Baseline
Sex
Time frame: At Baseline
Co-morbidity
Time frame: At Baseline
Healthcare utilization
Time frame: Up to 2 years
Primary Care Physicians visits, Outpatient visits and Hospital admissions
Proportion of Naive to non-naive patient
Time frame: At Baseline
Dose at first prescription
Time frame: Up to 6 years
Duration of treatment
Time frame: Up to 6 years
Discontinuation
Time frame: Up to 6 years
Switch to another study drug
Time frame: Up to 6 years

1 secondary outcome

Time trends of usage of study medications
Time frame: Up to 6 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Related InfoLink provided by the sponsor.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Bayer at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age (time frame: At Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03474757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.