Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Rivaroxaban (BAY59-7939); Drug: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329628

11354 (Registry Identifier)

EudraCT: 2005-004351-35

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 prevent blood clot which may form after total hip replacement operation.

Enrollment: 4,541 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

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4,541 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Arm 2

Active Comparator group

Treatment:

Drug: Enoxaparin