Status:
COMPLETED
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replace...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR
- Patients willing and able to undergo bilateral ascending contrast venography
- Key Exclusion Criteria
- Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
- Known or suspected history of heparin-induced thrombocytopenia
- Known coagulopathy
- Active bleeding or at high risk for bleeding
- Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
- Active hepatobiliary disease
- Alcohol and/or substance abuse within the past year
- Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
- Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
- Clinically significant laboratory abnormalities at the enrollment visit:
- Hemoglobin \<10 g/dL
- Platelet count \<100,000/mm\^3
- Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
- Alanine aminotransferase or aspartate aminotransferase level \>2\*upper limit of normal (ULN) or a total bilirubin ≥1.5\*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
3221 Patients enrolled
Trial Details
Trial ID
NCT00452530
Start Date
June 1 2007
End Date
January 1 2009
Last Update
July 9 2014
Active Locations (122)
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1
Local Institution
Graz, Austria, 8036
2
Local Institution
Innsbruck, Austria, 6020
3
Local Institution
Linz, Austria, 4010
4
Local Institution
Vienna, Austria, 1090