Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

Bayer

Status: Completed

Conditions: Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome; Venous Thrombosis

Treatments: Drug: Standard of care; Drug: Rivaroxaban (Xarelto, Bay59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01947959

EUPAS11145 (Registry Identifier)

XA1201 (Other Identifier)

16159

Details and patient eligibility

About

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Enrollment: 665,533 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Exclusion criteria

• Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day

Trial design

665,533 participants in 2 patient groups

Rivaroxaban

Description:

Patients who have been prescribed Rivaroxaban for the first time

Treatment:

Drug: Rivaroxaban (Xarelto, Bay59-7939)

Standard of care

Description:

Patients who have been prescribed Standard of care for the first time

Treatment:

Drug: Standard of care