Back to resultsA Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM150
mechanical prophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
YM150 group
mechanical prophylaxis group
Arm Description
Outcomes
Primary Outcome Measures
Composite assessment of venous thromboembolism events and all causes of death
Secondary Outcome Measures
Incidence of venous thromboembolism
Incidence of bleeding events
All cause mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00942435
Brief Title
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM150 group
Arm Type
Experimental
Arm Title
mechanical prophylaxis group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Intervention Type
Procedure
Intervention Name(s)
mechanical prophylaxis
Intervention Description
The investigator will determine the method of mechanical prophylaxis
Primary Outcome Measure Information:
Title
Composite assessment of venous thromboembolism events and all causes of death
Time Frame
Until day 12
Secondary Outcome Measure Information:
Title
Incidence of venous thromboembolism
Time Frame
Until day 28
Title
Incidence of bleeding events
Time Frame
Until day 28
Title
All cause mortality
Time Frame
Until day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Shikoku
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22762942
Citation
Sakon M, Nakamura M. Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III randomized, mechanical prophylaxis-controlled, open-label study. Thromb Res. 2012 Sep;130(3):e52-9. doi: 10.1016/j.thromres.2012.06.009. Epub 2012 Jul 2.
Results Reference
derived
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A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
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