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OpenTrials
Completed

NCT Number: NCT03474757

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. Age

    Time frame: At Baseline

  2. Sex

    Time frame: At Baseline

  3. Co-morbidity

    Time frame: At Baseline

  4. Healthcare utilization

    Time frame: Up to 2 years

    Primary Care Physicians visits, Outpatient visits and Hospital admissions

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: TREND

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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