Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement. (RECORD 4)

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Enoxaparin; Drug: Placebo: tablet of Rivaroxaban; Drug: Placebo: syringes of Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362232

11355

2006-002402-60 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Enrollment: 3,148 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 knee replacement

Exclusion criteria

• Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (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: Triple Blind

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3,148 participants in 2 patient groups

Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

Experimental group

Description:

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Treatment:

Drug: Placebo: syringes of Enoxaparin

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Enoxaparin 30 mg twice a day (bid)

Active Comparator group

Description:

Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Treatment:

Drug: Enoxaparin

Drug: Placebo: tablet of Rivaroxaban