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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Data Collection

• Registration Number: NCT03474757
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10528

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPAF patients in Colombia_Rivaroxaban	Data Collection	First time users of rivaroxaban in the Audifarma database
SPAF patients in Colombia_Dabigatran	Data Collection	First time users of dabigatran in the Audifarma database
SPAF patients in Colombia_Apixaban	Data Collection	First time users of apixaban in the Audifarma database

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time trends of usage of study medications	Up to 6 years

Trial Locations

Locations (1)

Many Locations; 🇨🇴 Multiple Locations, Colombia