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

Completed

• Conditions: Non-Valvular Atrial Fibrillation

• Registration Number: NCT02756481
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2015-10-09
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Women who were pregnant at any moment during the study period

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Hospitalization	approximately 2 years after enrollment
Frequency of Outpatient visits	approximately 2 years after enrollment
Duration of Hospitalization	approximately 2 years after enrollment

Secondary Outcome Measures

Name	Time	Method
Duration of Hospitalization due to Acute Myocardial Infarction (AMI)	Up to 3 years
Incidence of Cerebrovascular Disease (CVD)	Up to 3 years
Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)	Up to 3 years
Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)	Up to 3 years
Incidence of Systemic Embolism (SE)	Up to 3 years
Duration of Hospitalization 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
Frequency of Hospitalization due to Cerebrovascular Disease (CVD)	Up to 3 years
Incidence of Acute Myocardial Infarction (AMI)	Up to 3 years
Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)	Up to 3 years
Frequency of Outpatient Visits due to Systemic Embolism (SE)	Up to 3 years
Duration of Hospitalization due to Cerebrovascular Disease (CVD)	Up to 3 years
Frequency of Hospitalization due to Systemic Embolism (SE)	Up to 3 years