A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Daiichi Sankyo Co., Ltd.610 enrolled

Overview

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

610

Conditions

Prevention Venous Thromboembolism

Interventions

edoxabanDRUG

enoxaparin sodiumDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing unilateral total hip arthroplasty Exclusion Criteria: * Subjects with risks of hemorrhage * Subjects with thromboembolic risks * Subjects who weigh less than 40 kg * Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Locations (2)

Unnamed facility

Osaka, Japan

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of Subjects With Venous Thromboembolism Events

The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE

Time frame: 2 weeks

Secondary Outcomes

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding

Time frame: 2 weeks

Data from ClinicalTrials.gov

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