Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Anticoagulation Clinical Trial

Official title:

Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427516
• Other study ID #: CV185-374
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: September 19, 2016
• Start date: January 2009
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1144
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Badalona Serveis Assistencial, IMS Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%	Approximately 60 months	No
Secondary	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	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.	Approximately 60 months	No
Secondary	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	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.	Approximately 60 months	No

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