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

CompletedOBSERVATIONAL
Enrollment

99,999

Participants

Timeline

Start Date

June 15, 2015

Primary Completion Date

December 31, 2018

Study Completion Date

September 30, 2020

Conditions
Acute Coronary SyndromeVenous ThrombosisPulmonary EmbolismAtrial Fibrillation
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

"Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE (15 mg rivaroxaban twice daily \[bid\] for 3 weeks, then 15 mg or 20 mg once daily \[od\], tablets).~Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation \[SPAF\]) with one or more risk factors, prior stroke or transient ischaemic attack (20 mg rivaroxaban \[od\], tablets).~Prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban \[od\] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).~Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets \[bid\])."

DRUG

Standard of care drugs

For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.

Trial Locations (1)

Unknown

Many Locations, Multiple Locations

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

lead

Bayer

INDUSTRY