A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

Daiichi Sankyo903 enrolled

Overview

This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

903

Conditions

Thrombosis Hip Replacement

Interventions

DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitorDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

1. 18 years of age or older; male or female. 2. Able to provide written informed consent. 3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted. 4. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.

Locations (29)

Unnamed facility

Hartford, Connecticut, United States

Unnamed facility

Sarasota, Florida, United States

Outcomes

Primary Outcomes

Adjudicated Incidence of VTE

Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. A subject was judged to have a VTE if one or more of the following criteria were met: * Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit * Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit * Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.

Time frame: end of treatment

Secondary Outcomes

Change in Prothrombin Time (PT) From Baseline

change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery

Time frame: end of treatment

Change in Activated Partial Thromboplastin Time (aPTT) From Baseline

change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery

Time frame: end of treatment

Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events

adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose

Time frame: 10 days after first dose

Data from ClinicalTrials.gov

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