NCT01619007

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,145 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.

Conditions

• Deep Vein Thrombosis
• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
DRUG	Standard of care	Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2012-06-14
• Last updated: 2017-01-23

Locations

21 sites across 21 countries: Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Moldova, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom