Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

Astellas Pharma Inc1,141 enrolled

Overview

The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,141

Conditions

Thromboembolism

Interventions

YM150DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for elective primary hip replacement * Age 18 years or over * Written informed consent obtained Exclusion Criteria: * Documented history or considered at increased risk of venous thromboembolism * Subjects considered at increased risk of bleeding * Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment * Concomitant use of anticoagulants/ antiplatelet agents

Locations (79)

Outcomes

Primary Outcomes

Rate of total venous thromboembolism (VTE) during hospitalization phase

Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major

Secondary Outcomes

Proximal or distal deep vein thrombosis (DVT) during hospitalization phase

Symptomatic VTE

Rate of total VTE

Death due to any cause during treatment

Incidence of the bleeding types:

Major or clinically relevant non-major bleeding, Major bleeding,

Clinically relevant non-major bleeding, Minor bleeding

Data from ClinicalTrials.gov

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Innsbruck, Austria

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Vienna, Austria

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Vienna, Austria

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Foca, Bosnia and Herzegovina

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Sarajevo, Bosnia and Herzegovina

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Tuzla, Bosnia and Herzegovina

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Brno, Czechia

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Kladno, Czechia

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Prague, Czechia

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Třebíč, Czechia

...and 69 more locations