NCT02262676

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

October 9, 2014

Last Update Submit

January 20, 2017

Conditions

Atrial Fibrillation

Keywords

Stroke prevention on Atrial FibrillationPrevention and ControlStroke

Outcome Measures

Primary Outcomes (2)

  • Demographic Data

    At recruitment visit

  • Medical History

    At recruitment visit

Secondary Outcomes (4)

  • Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice

    At recruitment visit

  • Adherence to rivaroxaban treatment

    At recruitment visit

  • Assess the satisfaction of rivaroxaban treatment

    At recruitment visit

  • Assess the quality of life in patients

    At recruitment visit

Study Arms (1)

Rivaroxaban

Patients with Atrial fibrillation treated with Rivaroxaban

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Patients treated by Physicians under approved local prescriptions

Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients taking rivaroxaban for stroke prevention in atrial fibrillation attending consults of hematology, cardiology and internal medicine

You may qualify if:

  • Patients ≥ 18 years
  • Patients with atrial fibrillation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Spain

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

ES(1)