Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT02427516

Collaborator

Badalona Serveis Assistencials (Other), IMS Health (Other)

1,144

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation

Study Design

Study Type:

Observational

Actual Enrollment :

1144 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
NVAF-VKA cohort NVAF patients who initiate a VKA treatment
VTE-VKA cohort VTE patients who initiate a VKA treatment

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bristol-Myers Squibb
Badalona Serveis Assistencials
IMS Health

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

BMS clinical trial educational resource

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT02427516

Other Study ID Numbers:

CV185-374

First Posted:

Apr 28, 2015

Last Update Posted:

Sep 20, 2016

Last Verified:

Sep 1, 2016

Study Results

No Results Posted as of Sep 20, 2016