A phase 3, randomized, double-blind, active controlled (enoxaparin 40 mg QD), parallel-group, multi-center study to evaluate the safety and efficacy of Apixban in subjects ondergoing elective total knee replacement surgery.
Phase 3
Completed
- Conditions
- thrombosisembolie10014523
- Registration Number
- NL-OMON30891
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1) Subjects must undergo elective surgery for total knee replacement
2) At least 18 years of age
3) Subjects must be willing and able to undergo bilateral contrast venography
Exclusion Criteria
1) Known or suspected bleeding or coagulation disorder in the subject or a first degree relative
2) Known or suspected history of heparin-induced thrombocytopenia
3) Active bleeding or at high risk for bleeding
4) Need for ongoing treatment with a parenteral or oral anticoagulant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and<br /><br>all-cause death through Day 12 of double-blind treatment in subjects undergoing<br /><br>elective total knee replacement surgery.<br /><br><br /><br>Bleeding is the primary safety outcome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Composite of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal<br /><br>PE and VTE related death through Day 12 of double-blind treatment.</p><br>