Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain (HEROIC)

January 20, 2017 updated by: Bayer

Observational and Cross-sectional Study to Assess the Sociodemographic and Clinical Characteristics of Patients Treated With RIVAROXABAN in the Context of Routine Clinical Practice of Spanish Haematologists, Cardiologists and Internists (HEROIC Study)

Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2251

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

  • Spain
      • Many Locations, Spain

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients taking rivaroxaban for stroke prevention in atrial fibrillation attending consults of hematology, cardiology and internal medicine

Description

Inclusion Criteria:

  • Patients ≥ 18 years
  • Patients with atrial fibrillation
  • Patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at least 3 months previous to inclusion period in study

Exclusion Criteria:

  • Patients in treatment after start of study
  • Patients treated with other anticoagulant treatment

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
Rivaroxaban
Patients with Atrial fibrillation treated with Rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients treated by Physicians under approved local prescriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographic Data
Time Frame: At recruitment visit
At recruitment visit
Medical History
Time Frame: At recruitment visit
At recruitment visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice
Time Frame: At recruitment visit
By use of Informe de Posicionamiento Terapéutico (Spanish Questionnaire)
At recruitment visit
Adherence to rivaroxaban treatment
Time Frame: At recruitment visit
By use of Morisky-Green questionnaire
At recruitment visit
Assess the satisfaction of rivaroxaban treatment
Time Frame: At recruitment visit
By use of Anti-Clot Treatment Scale (ACTS) questionnaire
At recruitment visit
Assess the quality of life in patients
Time Frame: At recruitment visit
By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire
At recruitment visit

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

October 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17671

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.

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