Clinical trial NCT02756481: Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela
Official title: Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Valvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Hospitalization
timeFrame: approximately 2 years after enrollment
measure: Duration of Hospitalization
timeFrame: approximately 2 years after enrollment
measure: Frequency of Outpatient visits
timeFrame: approximately 2 years after enrollment
Secondary outcomes:
measure: Incidence of Cerebrovascular Disease (CVD)
timeFrame: Up to 3 years
measure: Frequency of Hospitalization due to Cerebrovascular Disease (CVD)
timeFrame: Up to 3 years
measure: Duration of Hospitalization due to Cerebrovascular Disease (CVD)
timeFrame: Up to 3 years
measure: Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)
timeFrame: Up to 3 years
measure: Incidence of Acute Myocardial Infarction (AMI)
timeFrame: Up to 3 years
measure: Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)
timeFrame: Up to 3 years
measure: Duration of Hospitalization due to Acute Myocardial Infarction (AMI)
timeFrame: Up to 3 years
measure: Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)
timeFrame: Up to 3 years
measure: Incidence of Systemic Embolism (SE)
timeFrame: Up to 3 years
measure: Frequency of Hospitalization due to Systemic Embolism (SE)
timeFrame: Up to 3 years
measure: Duration of Hospitalization due to Systemic Embolism (SE)
timeFrame: Up to 3 years
measure: Frequency of Outpatient Visits due to Systemic Embolism (SE)
timeFrame: Up to 3 years
measure: Incidence of Gastrointestinal Hemorrhage (GIH)
timeFrame: Up to 3 years
measure: Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
timeFrame: Up to 3 years
measure: Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
timeFrame: Up to 3 years
measure: Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH)
timeFrame: Up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: