check_circleStudy 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
  • - 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


  • - 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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Colombia

Primary Outcome

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

Secondary Outcome

  • Time trends of usage of study medications
    date_rangeTime 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

Additional Information