check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

17671

ClinicalTrials.gov Identifier:

NCT02262676

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational study to assess sociodemographic and clinical features of patients treated with rivaroxaban in routine clinical practice of hematologists, cardiologists and internists of Spain

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

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

Trial summary

Enrollment Goal
2251
Trial Dates
October 2014 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • Demographic Data
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No
  • Medical History
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No
  • Adherence to rivaroxaban treatment
    By use of Morisky-Green questionnaire
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No
  • Assess the satisfaction of rivaroxaban treatment
    By use of Anti-Clot Treatment Scale (ACTS) questionnaire
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No
  • Assess the quality of life in patients
    By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire
    date_rangeTime Frame:
    At recruitment visit
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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