Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

NCT ID: NCT02427516

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Anticoagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NVAF-VKA cohort

NVAF patients who initiate a VKA treatment

No interventions assigned to this group

VTE-VKA cohort

VTE patients who initiate a VKA treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Badalona Serveis Assistencials

OTHER

Sponsor Role collaborator

IMS Health

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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Other Identifiers

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CV185-374

Identifier Type: -

Identifier Source: org_study_id

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