Study Completed

Atrial Fibrillation

Bayer Identifier:

20104

ClinicalTrials.gov Identifier:

NCT03474757

EudraCT Number:

Not Available

EU CT Number:

Not Available

Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

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
- 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 summary

Enrollment Goal

10528

Trial Dates

February 2018 - July 2018

Phase

Phase 4

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Colombia

Primary Outcome

Age
Time Frame:
At Baseline
Sex
Time Frame:
At Baseline
Co-morbidity
Time Frame:
At Baseline
Healthcare utilization
Primary Care Physicians visits, Outpatient visits and Hospital admissions
Time Frame:
Up to 2 years
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

Secondary Outcome

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

Trial design

Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases – TREND Colombia

Trial Type

Observational

Intervention Type

Other

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A