Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events

NCT ID: NCT03462446

Last Updated: 2018-03-12

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

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-05-01

Brief Summary

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The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Treatment group with Rivaroxaban

Patients treated with Rivaroxaban

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

As prescribed by treating physicians

Control group with VKAs

Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%).

Vitamin K antagonists (VKAs)

Intervention Type DRUG

As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

Intervention Type DRUG

Vitamin K antagonists (VKAs)

As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Diagnosis of non-valvular AF (ICD code 427.31)
* Pharmacological treatment with VKAs or rivaroxaban following diagnosis

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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18231

Identifier Type: -

Identifier Source: org_study_id

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