Subjects undergoing elective total hip replacement (THR) surgery MedDRA version: 9.1 Level: LLT Classification code 10051055 Term: Deep vein thrombosis MedDRA version: 9.1 Level: LLT Classification code 10037377 Term: Pulmonary embolism
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent Target population 2) Subjects undergoing elective unilateral total hip replacement or a revision of at least one component of a total hip replacement. 3) Subject must be willing and able to undergo bilateral ascending contrast venography. Unless Investigator/radiologist can assure that a bilateral venogram can be performed, subjects exceeding 300 lbs. (136 kg) and/or BMI = 35 kg/m2 are to be excluded because of technical limitations due to body habitus. Age and Sex 4) Men and women, of any race, at least 18 (or legal age of consent if greater) years of age 5) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the treatment period of the study in such a manner that the risk of pregnancy is minimized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sex and Reproductive Status 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period of the study 2) Women who are pregnant or breastfeeding 3) Women with a positive pregnancy test on enrollment or prior to investigational product administration Target Disease Exceptions 4) Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative 5) Known or suspected history of heparin-induced thrombocytopenia 6) Known coagulopathy 7) Active bleeding or at high risk for bleeding Medical History and Concurrent Diseases 8) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days 9) Active hepatobiliary disease 10) Alcohol and/or substance abuse within the past year 11) Any condition, in the opinion of the Investigator, for which surgery or administration of an anticoagulant is contraindicated Physical and Laboratory Test Findings 12) Two consecutive blood pressure readings within 15-30 minutes with supine SBP > 180 mm Hg or supine DBP > 105 mm Hg 13) Hemoglobin 2xULN or a Total Bilirubin = 1.5xULN (unless an alternative causative factor [e.g., Gilbert’s syndrome] is identified) Allergies and Adverse Drug Reactions 17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin (LMWH), porcine products, or iodinated contrast medium (for venogram) Prohibited Treatments and/or Therapies 18) Need for ongoing treatment with a parenteral or oral anticoagulant (e.g., subjects with mechanical valves, warfarin eligible atrial fibrillation) 19) Current use of dextrans or fibrinolytics 20) Treatment with medications affecting coagulation or platelet function unless they can be withdrawn as follows: • Unfractionated heparin, LMWH, warfarin (or any other VKA), glycoprotein IIb/IIIa inhibitors (e.g., abciximab, eptifibatide, tirofiban) within 4 days before surgery • Clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone within 7 days before surgery • Non-selective NSAIDs with a T1/2 greater than 17 hours within 7 days before surgery • Fondaparinux within 7 days before surgery • Acetylsalicylic acid > 165 mg within 4 days before surgery 21) Planned indwelling intrathecal or epidural catheter that can not be removed at least 5 hours prior to first dose of post-operative study drug. Other Exclusion Criteria 22) Prisoners or subjects who are compulsorily detained 23) Subjects who have been previously randomized into an apixaban clinical trial 24) Administration of any investigational drug currently or within 30 days prior to enrollment into this study 25) Any other contra-indication listed in the country specific labelinig for enoxaparin BMS will also include country-specific contra-indications for enoxaparin in the training information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of oral (PO) apixaban 2.5 mg BID versus subcutaneous (SC) enoxaparin 40 mg QD on the composite endpoint of adjudicated asymptomatic and symptomatic deep-vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all cause death during 35 days of double-blind treatment in subjects undergoing elective total hip replacement surgery.;Primary end point(s): Composite of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death during 35 days of double-blind treatment in subjects undergoing elective total hip replacement surgery.;Secondary Objective: 1/ compare the effect of oral apixaban 2.5 mg BID vs SC enoxaparin 40 mg QD on the composite of adjudicated proximal DVT, non-fatal PE & VTE-related death during 35 days of DB treatment. 2/ assess the effect of oral apixaban 2.5 mg BID vs SC enoxaparin 40 mg QD on: • composite of adjudicated asymptomatic & symptomatic DVT, non-fatal PE & VTE-related death during 35 days of DB treatment • composite of adjudicated proximal DVT, non-fatal PE and all cause death after 35 days of DB treatment. • single adjudicated endpoints of distal DVT, proximal DVT, non-fatal PE, VTE related deaths, and all-cause death during 35 days of DB treatment • adjudicated major bleeding events during 35 days of DB treatment • composite of adjudicated major and clinically relevant non-major bleeding events during 35 days of DB treatment • adjudicated clinically relevant non-major bleeding during 35 days of DB treatment 3/ assess overall safety & tolerability of both treatment arms | — |
Countries
Belgium, Denmark, France, Germany, Hungary, Spain, Sweden, United Kingdom
Outcome results
None listed