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

Atrial Fibrillation Clinical Trial

— HEROIC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262676
• Other study ID #: 17671
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: January 20, 2017
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2251
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Spain, 

Outcome

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

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