Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela

Study Overview
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Brief Summary
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To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.

Official Title
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Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela

Conditions
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Non-Valvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of AF (incident and prevalent cases) Patient with at least 18 years Patients enrolment before and during the study period Patients treated in Venezuela Exclusion Criteria: Women who were pregnant at any moment during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NVAF Treatment patterns<br>Treatment patterns will be collected during the follow-up period. Data will be directly extracted from medical charts of the arrhythmia unit. Anticoagulation use will be reported as drug class: Vitamin K antagonist, antiplatelet, nonsteroidal anti-inflammatory drugs. The following data on anticoagulation use will be collected: Type of treatment, start & stop dates, dosage, administration schedule, method of administration, reason for discontinuation if applicable Type of therapy utilized (monotherapy/combination therapy) Total number of therapy changes or switches through the course of treatment Monitoring visit (visits per month) for International normalized ratio (INR) control by Time in Therapeutic Range(cTTR) Routine care (visits per month) by anticoagulation regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Hospitalization |  | approximately 2 years after enrollment | 
| Duration of Hospitalization |  | approximately 2 years after enrollment | 
| Frequency of Outpatient visits |  | approximately 2 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cerebrovascular Disease (CVD) |  | Up to 3 years | 
| Frequency of Hospitalization due to Cerebrovascular Disease (CVD) |  | Up to 3 years | 
| Duration of Hospitalization due to Cerebrovascular Disease (CVD) |  | Up to 3 years | 
| Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD) |  | Up to 3 years | 
| Incidence of Acute Myocardial Infarction (AMI) |  | Up to 3 years | 
| Frequency of Hospitalization due to Acute Myocardial Infarction (AMI) |  | Up to 3 years | 
| Duration of Hospitalization due to Acute Myocardial Infarction (AMI) |  | Up to 3 years | 
| Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI) |  | Up to 3 years | 
| Incidence of Systemic Embolism (SE) |  | Up to 3 years | 
| Frequency of Hospitalization due to Systemic Embolism (SE) |  | Up to 3 years | 
| Duration of Hospitalization due to Systemic Embolism (SE) |  | Up to 3 years | 
| Frequency of Outpatient Visits due to Systemic Embolism (SE) |  | Up to 3 years | 
| Incidence of Gastrointestinal Hemorrhage (GIH) |  | Up to 3 years | 
| Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH) |  | Up to 3 years | 
| Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH) |  | Up to 3 years | 
| Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH) |  | Up to 3 years |