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

Atrial Fibrillation Clinical Trial

— TREND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474757
• Other study ID #: 20104
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10528
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Data Collection
Data will be extracted from July 2009 to the last available database extraction

Locations

Country	Name	City	State
Colombia	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Colombia, 

Outcome

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

External Links

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