Trial Condition(s):
Atrial Fibrillation
Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases (TREND)
Bayer Identifier:
20104
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: 1-888-8422937 |
Trial Design
Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases – TREND Colombia
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- AgeTimeframe: At Baseline
- SexTimeframe: At Baseline
- Co-morbidityTimeframe: At Baseline
- Healthcare utilizationPrimary Care Physicians visits, Outpatient visits and Hospital admissionsTimeframe: Up to 2 years
- Proportion of Naive to non-naive patientTimeframe: At Baseline
- Dose at first prescriptionTimeframe: Up to 6 years
- Duration of treatmentTimeframe: Up to 6 years
- DiscontinuationTimeframe: Up to 6 years
- Switch to another study drugTimeframe: Up to 6 years
Secondary Outcome
- Time trends of usage of study medicationsTimeframe: Up to 6 years
Additional Information
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