Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement (RECORD 2)
Status and phase
Completed
Phase 3
Conditions
Venous Thromboembolism
Prevention
Treatments
Drug: Rivaroxaban (BAY59-7939)
Drug: Enoxaparin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
2,457 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Exclusion criteria
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
2,457 participants in 2 patient groups
Arm 1
Experimental group
Treatment:
Drug: Rivaroxaban (BAY59-7939)
Arm 2
Active Comparator group
Treatment:
Drug: Enoxaparin
Trial contacts and locations
126
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Data sourced from clinicaltrials.gov
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