EUCTR2006-005351-14-DK进行中（未招募）不适用
A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery ( The ADVANCE-3 study Apixaban Dosed Orally Versus AntiCoagulation with Injectable Enoxaparin to Prevent Venous Thromboembolism)+ Pharmacogenetics Blood Sample Amendment 01 (Version 1.0 - dated 27-Nov-2006)Revised Protocol 01, incorporating Protocol Amendment 02 and Admin. Letter 01 ( Version 3.0, Dated 21-Jun-2007)Protocol Amendment 03 (Version 1.0 - dated 29-Apr-08)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,947
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 < 10 g/dL
- •14) Platelet count < 100,000/mm3
- •15) Creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault (see protocol Section 6.3.4)
- •16) Active hepatobiliary disease, based on an ALT or AST > 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 labeling for enoxaparin BMS will also include country-specific contra-indications for enoxaparin in the training information
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