A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

Astellas Pharma Inc685 enrolled

Overview

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

685

Conditions

Arthroplasty, Replacement, Knee

Interventions

YM150DRUG

Oral

WarfarinDRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is scheduled for elective primary knee arthroplasty * Written Informed consent obtained Exclusion Criteria: * Subject has documented history of previous VTE * Subject is considered to be at increased risk of VTE * Subject has active bleeding or any condition associated with increased risk of bleeding * Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Locations (54)

Outcomes

Primary Outcomes

The incidence of total venous thromboembolisms (VTE).

Time frame: 6 Weeks

The incidence of bleeding events classified as major by the Adjudication Committee

Time frame: 6 Weeks

Secondary Outcomes

Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause

Time frame: 6 Weeks

Incidence of the bleeding types: major, clinically relevant nonmajor, minor

Time frame: 6 Weeks

Data from ClinicalTrials.gov

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Unnamed facility

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tuscon, Arizona, United States

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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San Diego, California, United States

Unnamed facility

Santa Ana, California, United States

...and 44 more locations