NCT00361894 - 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. | Crick | Crick

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.

Phase 3CompletedNCT00361894

Bayer2,531 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,531

Conditions

Prevention Venous Thromboembolism

Interventions

Rivaroxaban (BAY59-7939)DRUG

10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days

Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (143)

Outcomes

Primary Outcomes

Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes

Time frame: Treatment period: up to Day 13+/-4

Secondary Outcomes

Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)

Time frame: Treatment period: up to Day 13+/-4

Incidence of symptomatic VTE (DVT, PE)

Time frame: Treatment period: up to Day 13+/-4

Incidence of DVT (total, proximal, distal)

Time frame: Treatment period: up to Day 13+/-4

Incidence of symptomatic VTE during follow-up

Time frame: Follow-up period: following 13+/-4 days

The composite endpoint comprising major VTE and treatment-emergent major bleeding

Time frame: For major VTE, treatment period: up to Day 13+/-4 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death

Time frame: Treatment period: up to Day 13+/-4

Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death

Time frame: Treatment period: up to Day 13+/-4

Treatment-emergent major bleedings

Time frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Data from ClinicalTrials.gov

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