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OpenTrials
Completed

NCT Number: NCT02756481

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

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

Completed

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of Hospitalization

    Time frame: approximately 2 years after enrollment

  2. Duration of Hospitalization

    Time frame: approximately 2 years after enrollment

  3. Frequency of Outpatient visits

    Time frame: approximately 2 years after enrollment

Secondary outcomes

  1. Incidence of Cerebrovascular Disease (CVD)

    Time frame: Up to 3 years

  2. Frequency of Hospitalization due to Cerebrovascular Disease (CVD)

    Time frame: Up to 3 years

  3. Duration of Hospitalization due to Cerebrovascular Disease (CVD)

    Time frame: Up to 3 years

  4. Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)

    Time frame: Up to 3 years

  5. Incidence of Acute Myocardial Infarction (AMI)

    Time frame: Up to 3 years

  6. Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)

    Time frame: Up to 3 years

  7. Duration of Hospitalization due to Acute Myocardial Infarction (AMI)

    Time frame: Up to 3 years

  8. Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)

    Time frame: Up to 3 years

  9. Incidence of Systemic Embolism (SE)

    Time frame: Up to 3 years

  10. Frequency of Hospitalization due to Systemic Embolism (SE)

    Time frame: Up to 3 years

  11. Duration of Hospitalization due to Systemic Embolism (SE)

    Time frame: Up to 3 years

  12. Frequency of Outpatient Visits due to Systemic Embolism (SE)

    Time frame: Up to 3 years

  13. Incidence of Gastrointestinal Hemorrhage (GIH)

    Time frame: Up to 3 years

  14. Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH)

    Time frame: Up to 3 years

  15. Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH)

    Time frame: Up to 3 years

  16. Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH)

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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