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Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

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Bayer

Status

Completed

Conditions

Pulmonary Embolism
Atrial Fibrillation
Acute Coronary Syndrome
Venous Thrombosis

Treatments

Drug: Rivaroxoban (Xarelto, Bay59-7939)
Drug: Standard of care

Study type

Observational

Funder types

Industry

Identifiers

NCT01947985
16646
EUPAS11141 (Registry Identifier)

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 Acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Enrollment

208,958 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 will be excluded

Trial design

208,958 participants in 2 patient groups

Rivaroxoban
Description:
Patients who have been prescribed Rivaroxaban for the first time
Treatment:
Drug: Rivaroxoban (Xarelto, Bay59-7939)
Standard of care
Description:
Patients who have been prescribed standard of care for the first time
Treatment:
Drug: Standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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