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OpenTrials
Completed

NCT Number: NCT02262676

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Patients treated by Physicians under approved local prescriptions

Primary outcomes

  1. Demographic Data

    Time frame: At recruitment visit

  2. Medical History

    Time frame: At recruitment visit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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)

Acronym: HEROIC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 13, 2014
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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