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CompletedNCT02262676HEROICUpdated Jan 23, 2017

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

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,251
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Atrial Fibrillation

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Keywords

  • Stroke prevention on Atrial Fibrillation
  • Prevention and Control
  • Stroke
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 2,251 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 56 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 130 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Patients in treatment after start of study
  • Patients treated with other anticoagulant treatment
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,251 participants (actual)

Groups and cohorts

  • Rivaroxaban

    Patients with Atrial fibrillation treated with Rivaroxaban

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

  • DrugRivaroxaban (Xarelto, BAY59-7939)

    Patients treated by Physicians under approved local prescriptions

06

What researchers measure

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

    By use of Informe de Posicionamiento Terapéutico (Spanish Questionnaire)

    Time frame: At recruitment visit

  2. Adherence to rivaroxaban treatment

    By use of Morisky-Green questionnaire

    Time frame: At recruitment visit

  3. Assess the satisfaction of rivaroxaban treatment

    By use of Anti-Clot Treatment Scale (ACTS) questionnaire

    Time frame: At recruitment visit

  4. Assess the quality of life in patients

    By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire

    Time frame: At recruitment visit

07

Study locations

1 site
  • Many Locations, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02262676
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Oct 2014
Primary completion
Feb 2015
Completion
May 2015
Last update
Jan 23, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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