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

NCT ID: NCT03474757

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10528 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2018-07-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SPAF patients in Colombia_Rivaroxaban

First time users of rivaroxaban in the Audifarma database

Data Collection

Intervention Type OTHER

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

Data Collection

Intervention Type OTHER

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

Data Collection

Intervention Type OTHER

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

Interventions

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Data Collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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20104

Identifier Type: -

Identifier Source: org_study_id

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