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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM150 group | Experimental |
| |
| mechanical prophylaxis group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
| |
| mechanical prophylaxis |
| Measure | Description | Time Frame |
|---|---|---|
| Composite assessment of venous thromboembolism events and all causes of death | Until day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of venous thromboembolism | Until day 28 | |
| Incidence of bleeding events | Until day 28 | |
| All cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22762942 | Derived | 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. |
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| Procedure |
The investigator will determine the method of mechanical prophylaxis |
|
| Until day 28 |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Shikoku | Japan |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D006470 | Hemorrhage |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013927 | Thrombosis |
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