Status:
COMPLETED
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
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 can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery an...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
- Patients who were willing and able to undergo bilateral ascending contrast venography
- Either sex, any race, 18 years and older
- Key Exclusion Criteria
- Known or suspected bleeding or coagulation disorder in the patient 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 surgery or administration of an anticoagulant is 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 \>2\*upper limit of normal or a total bilirubin ≥ 1.5\*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
- Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
- Current use of dextrans or fibrinolytics
- Treatment with medications affecting coagulation or platelet function
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
5407 Patients enrolled
Trial Details
Trial ID
NCT00423319
Start Date
March 1 2007
End Date
September 1 2009
Last Update
May 14 2014
Active Locations (143)
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1
Capstone Clinical Trials, Inc
Birmingham, Alabama, United States, 35209
2
West Alabama Research, Llc
Birmingham, Alabama, United States, 35209
3
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States, 72205
4
Orthoarkansas, P.A.
Little Rock, Arkansas, United States, 72205