Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. (RECORD 3)

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism; Prevention

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00361894

EudraCT: 2005-004620-40

11356 (Registry Identifier)

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 prevents blood clot which may form after a knee replacement operation.

Enrollment: 2,531 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement Exclusion Criteria:- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,531 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Arm 2

Active Comparator group

Treatment:

Drug: Enoxaparin