Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Completed

• Conditions: Anticoagulation

• Registration Number: NCT02427516
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1144

Inclusion Criteria

• Patients aged 18 or older over the study period
• Patients with a diagnosis for NVAF or VTE anytime in their medical records
• Patients having at least one year of enrolment in the database prior to the index date
• Patients newly initiated with VKA during the study period (index date)

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Exclusion Criteria

• Patients with a diagnosis for both NVAF and VTE anytime in their medical records

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annualized total and per patient cost of patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Per patient cost: direct medical costs from hospitalizations, consultations, medications, and tests; Coagulation control status: adequately controlled patients defined by INR between 2-3 and TTR≥ 60%

Secondary Outcome Measures

Name	Time	Method
Demographic and clinical characteristics for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Variables measured: age, gender, employment status, smoking status, BMI, major co-morbidities (including CHARLSON index), CHA2DS2-VASc score, presence and frequency of INR measurement, and INR therapeutic range.
Healthcare resource rates for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records	Approximately 60 months	Healthcare resources used (i.e. hospitalizations, consultations, medication, and tests) by patients will be measured according to coagulation control status. For each healthcare resource the number and percentage of patients using it and the mean, SD, median min, max and valid n will be reported; as well as the number of times that each patient uses the resource.