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Rivaroxaban (10mg) Given Once...

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

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Rivaroxaban (BAY59-7939)

Intervention Type DRUG

10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days

Arm 2

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days

Interventions

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Rivaroxaban (BAY59-7939)

10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days

Intervention Type DRUG

Enoxaparin

Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Birmingham, Alabama, United States

Site Status

Northport, Alabama, United States

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Phoenix, Arizona, United States

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Benton, Arkansas, United States

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La Jolla, California, United States

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Aurora, Colorado, United States

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Decatur, Georgia, United States

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Missoula, Montana, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Grapevine, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Avellaneda, Buenos Aires, Argentina

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Berazategui, Buenos Aires, Argentina

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