Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

Phase 3CompletedNCT00332020

Bayer2,457 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 can help prevent blood clots forming after a hip replacement operation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,457

Conditions

Prevention Venous Thromboembolism

Interventions

Rivaroxaban (BAY59-7939)DRUG

10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

40 mg enoxaparin syringe administered for 12 +/- 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 (126)

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 35+/-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 35+/-6

Incidence of symptomatic VTE (DVT, PE)

Time frame: Treatment period: up to day 35+/-6

Incidence of DVT (total, proximal, distal)

Time frame: Treatment period: up to day 35+/-6

Incidence of symptomatic VTE during follow-up

Time frame: Follow-up period: following 35+/-6 days

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

Time frame: For major VTE, treatment period: up to Day 35+/-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 35+/-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 35+/-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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

NCT00332020 - Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement | Crick | Crick