NCT02427516

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,144

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

6.3 years

First QC Date

April 23, 2015

Last Update Submit

September 19, 2016

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

NVAF-VKA cohort

NVAF patients who initiate a VKA treatment

VTE-VKA cohort

VTE patients who initiate a VKA treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with NVAF or VTE and treated with VKA

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

January 1, 2009

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

September 20, 2016

Record last verified: 2016-09