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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Data Collection

• Study Type: Observational
• Enrollment (Actual): 10528

Contacts and Locations

Study Locations

• Colombia
  • Multiple Locations, Colombia
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SPAF patients in Colombia_Rivaroxaban; First time users of rivaroxaban in the Audifarma database	Other: Data Collection; Data will be extracted from July 2009 to the last available database extraction
SPAF patients in Colombia_Dabigatran; First time users of dabigatran in the Audifarma database	Other: Data Collection; Data will be extracted from July 2009 to the last available database extraction
SPAF patients in Colombia_Apixaban; First time users of apixaban in the Audifarma database	Other: Data Collection; Data will be extracted from July 2009 to the last available database extraction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Time trends of usage of study medications	Up to 6 years

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No