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

March 9, 2018 updated by: Bayer

Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group with Rivaroxaban
Patients treated with Rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
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%).
Drug: Vitamin K antagonists (VKAs)
As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in therapeutic range (TTR) values in the last 6 months
Time Frame: 6 months
6 months
Presence of stroke
Time Frame: 12 months
Presence of stroke prior and subsequent to treatment
12 months
Active substance received
Time Frame: 12 months
Rivaroxaban or VKAs (Acenocoumarol and Warfarin)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Date of stroke
Time Frame: 12 months
12 months
Type of stroke
Time Frame: 12 months
Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.
12 months
Duration of treatment (in days)
Time Frame: 12 months
12 months
Dose of the prescribed treatment
Time Frame: 12 months
12 months
Frequency of the prescribed treatment (in hours)
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Date of AF diagnosis
Time Frame: 12 months
12 months
Comorbidities
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Rivaroxaban (Xarelto, BAY59-7939)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe