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Trial record 1 of 1 for:    NCT02262676
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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)

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ClinicalTrials.gov Identifier: NCT02262676
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Design
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Study Type : Observational
Actual Enrollment : 2251 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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)
Study Start Date : October 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Demographic Data [ Time Frame: At recruitment visit ]
  2. Medical History [ Time Frame: At recruitment visit ]

Secondary Outcome Measures :
  1. 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)

  2. Adherence to rivaroxaban treatment [ Time Frame: At recruitment visit ]
    By use of Morisky-Green questionnaire

  3. Assess the satisfaction of rivaroxaban treatment [ Time Frame: At recruitment visit ]
    By use of Anti-Clot Treatment Scale (ACTS) questionnaire

  4. Assess the quality of life in patients [ Time Frame: At recruitment visit ]
    By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients taking rivaroxaban for stroke prevention in atrial fibrillation attending consults of hematology, cardiology and internal medicine
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262676


Locations
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Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02262676    
Other Study ID Numbers: 17671
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Bayer:
Stroke prevention on Atrial Fibrillation
Prevention and Control
Stroke
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants