A Phase 3 interventional study of Rivaroxaban (BAY59-7939) and Enoxaparin in Prevention and Venous Thromboembolism, sponsored by Bayer. Completed at 126 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 2,457 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Rivaroxaban (BAY59-7939)
Drug: Enoxaparin
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
40 mg enoxaparin syringe administered for 12 +/- 2 days
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
Time frame: Treatment period: up to day 35+/-6
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Time frame: Treatment period: up to day 35+/-6
Incidence of symptomatic VTE (DVT, PE)
Time frame: Treatment period: up to day 35+/-6
Incidence of DVT (total, proximal, distal)
Time frame: Treatment period: up to day 35+/-6
Incidence of symptomatic VTE during follow-up
Time frame: Follow-up period: following 35+/-6 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time frame: For major VTE, treatment period: up to Day 35+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Time frame: Treatment period: up to day 35+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
Time frame: Treatment period: up to day 35+/-6
Treatment-emergent major bleedings
Time frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Showing the first 100 of 126 sites across 23 countries.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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