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
1 other identifier
interventional
156
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 16, 2010
June 1, 2010
10 months
July 16, 2009
June 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite assessment of venous thromboembolism events and all causes of death
Until day 12
Secondary Outcomes (3)
Incidence of venous thromboembolism
Until day 28
Incidence of bleeding events
Until day 28
All cause mortality
Until day 28
Study Arms (2)
YM150 group
EXPERIMENTALmechanical prophylaxis group
ACTIVE COMPARATORInterventions
The investigator will determine the method of mechanical prophylaxis
Eligibility Criteria
You may qualify if:
- Patients after a major abdominal surgery
- Written informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Shikoku, Japan
Related Publications (1)
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.
PMID: 22762942DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 16, 2009
First Posted
July 20, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 16, 2010
Record last verified: 2010-06