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

NCT02756481 | Completed

• 1 other identifier: CV185-333
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• 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

Study Arms (1)

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 treatment * Monitoring visit (visits per month) for International normalized ratio (INR) control by Time in Therapeutic Range(cTTR) * Routine care (visits per month) by anticoagulation regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: April 29, 2016
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 29, 2016

Record last verified: 2016-04