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

Phase 3CompletedNCT00329628

Bayer4,541 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 prevent blood clot which may form after total hip replacement operation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

4,541

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban (BAY59-7939)DRUG

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

Syringe of Enoxaparin active substance at a dose of 40 mg administered 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 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)

Locations (215)

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 36+/-6

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 36+/-6

Incidence of symptomatic VTE (DVT, PE)

Time frame: Treatment period : up to day 36+/-6

Incidence of DVT (total, proximal, distal)

Time frame: Treatment period : up to day 36+/-6

Incidence of symptomatic VTE during follow-up

Time frame: Follow-up period: following 36+/-6 days

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

Time frame: For major VTE, treatment period: up to Day 36+/-6 ; 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 36+/-6

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 36+/-6

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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NCT00329628 - Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin | Crick | Crick