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

NCT03474757 | Completed

• 1 other identifier: 20104
• Study Type: observational
• Target: 10,528
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Time trends of usage of study medications

  Up to 6 years

Study Arms (3)

SPAF patients in Colombia_Rivaroxaban

First time users of rivaroxaban in the Audifarma database

Other: Data Collection

SPAF patients in Colombia_Dabigatran

First time users of dabigatran in the Audifarma database

Other: Data Collection

SPAF patients in Colombia_Apixaban

First time users of apixaban in the Audifarma database

Other: Data Collection

Interventions

Data Collection OTHER

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

SPAF patients in Colombia_Apixaban; SPAF patients in Colombia_Dabigatran; SPAF patients in Colombia_Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many Locations

Multiple Locations, Colombia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 23, 2018
• Study Start: February 28, 2018
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

CO (1)