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

Bayer

Status: Completed

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

Treatments: Drug: Standard of care drugs; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02468102

XA1405SE (Other Identifier)

17543

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 standard of care for the first time.

The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Enrollment: 99,999 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018

Exclusion criteria

• For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded

Trial design

99,999 participants in 2 patient groups

Rivaroxaban / Cohort 1

Description:

Patients who have filled a prescription for rivaroxaban in any pharmacy in Sweden during the study period.

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Standard of care drugs / Cohort 2

Description:

Patients who have filled a prescription for standard of care drugs (warfarin, aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor) in any pharmacy in Sweden during the study period.

Treatment:

Drug: Standard of care drugs