A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942435

Enrollment

156

Registered

2009-07-20

Start date

2009-06-30

Completion date

2010-04-30

Last updated

2010-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism

Brief summary

The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.

Interventions

DRUGYM150

oral

PROCEDUREmechanical prophylaxis

The investigator will determine the method of mechanical prophylaxis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients after a major abdominal surgery * Written informed consent obtained

Exclusion criteria

* Subject has history of symptomatic deep vein thrombosis and/or pulmonary embolism * Subject has a hemorrhagic disorder and/or coagulation disorder * Subject has had clinically important bleeding occurred within 90 days prior to the screening visit * Subject has an active bacterial endocarditis * Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke * Subject is receiving anticoagulants/antiplatelet agents * Subject has a thrombocytopenia * Body weight less than 40 kg at the screening

Design outcomes

Primary

Measure	Time frame
Composite assessment of venous thromboembolism events and all causes of death	Until day 12

Secondary

Measure	Time frame
Incidence of venous thromboembolism	Until day 28
Incidence of bleeding events	Until day 28
All cause mortality	Until day 28

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026