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

Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela

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

Study Overview

• Status: Completed
• Conditions: Non-Valvular Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This observational, non-interventional, retrospective and longitudinal study of NVAF patients in the private sector in Venezuela based on two study samples to be analyzed separately, medical chart review and an electronic database analysis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

NVAF Treatment patterns; 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 treatmentMonitoring 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?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CV185-333