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

Non-Valvular Atrial Fibrillation Clinical Trial

Official title:

Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756481
• Other study ID #: CV185-333
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: April 27, 2016
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Hospitalization		approximately 2 years after enrollment	No
Primary	Duration of Hospitalization		approximately 2 years after enrollment	No
Primary	Frequency of Outpatient visits		approximately 2 years after enrollment	No
Secondary	Incidence of Cerebrovascular Disease (CVD)		Up to 3 years	No
Secondary	Frequency of Hospitalization due to Cerebrovascular Disease (CVD)		Up to 3 years	No
Secondary	Duration of Hospitalization due to Cerebrovascular Disease (CVD)		Up to 3 years	No
Secondary	Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)		Up to 3 years	No
Secondary	Incidence of Acute Myocardial Infarction (AMI)		Up to 3 years	No
Secondary	Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)		Up to 3 years	No
Secondary	Duration of Hospitalization due to Acute Myocardial Infarction (AMI)		Up to 3 years	No
Secondary	Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)		Up to 3 years	No
Secondary	Incidence of Systemic Embolism (SE)		Up to 3 years	No
Secondary	Frequency of Hospitalization due to Systemic Embolism (SE)		Up to 3 years	No
Secondary	Duration of Hospitalization due to Systemic Embolism (SE)		Up to 3 years	No
Secondary	Frequency of Outpatient Visits due to Systemic Embolism (SE)		Up to 3 years	No
Secondary	Incidence of Gastrointestinal Hemorrhage (GIH)		Up to 3 years	No
Secondary	Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH)		Up to 3 years	No
Secondary	Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH)		Up to 3 years	No
Secondary	Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH)		Up to 3 years	No

External Links

•   BMS Clinical Trial Information
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