NCT01947985

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

A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 208,958 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Thrombosis
• Pulmonary Embolism
• Atrial Fibrillation
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Rivaroxoban (Xarelto, Bay59-7939)	The treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily \[bid\] for 3 weeks, then 15 mg or 20 mg once daily \[od\], tablets). The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation \[SPAF\]) with one or more risk factors (20 mg rivaroxaban \[od\], tablets). The prevention of venous thromboembolism (VTE) in adult 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 adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets \[bid\]).
DRUG	Standard of care	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2018-12-31
• Completion: 2020-09-30
• First posted: 2013-09-23
• Last updated: 2021-09-27

Locations

1 site across 1 country: Netherlands