EUCTR2006-006896-19-SE进行中（未招募）不适用
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery. Revised Protocol 02: Incorporating Protocol Amendment 02 (v2.0, date 18-Apr-2007) and Protocol Amendment 04 (v2.0, date 05-May-2008).And Pharmacogenetics Blood Sample Amendment 01 (v2.0, date 31-Jan-2007)And Revised Protocol 03 incorporating protocol Amendment 05 (v1.0 dated 31-Oct-2008 and Admin letter 02 (v2.0 dated 12-Jun-2008) - The ADVANCE - 2 Study
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
- 3,670
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) Subjects must be willing and able to give written informed consent. Consent to
- •participate in the study must be obtained prior to any screening procedures.
- •2) Subjects undergoing elective unilateral or bilateral same day total knee replacement or a revision of at least one component of a total knee replacement.
- •3) Subject must be willing and able to undergo bilateral ascending contrast
- •venography.
- •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. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
- •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
- •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
- •4) Known or suspected or acquired 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
- •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
- •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 Section 6.3.4)
- •16) ALT or AST > 2 x ULN or a Total Bilirubin = 1.5 x ULN (unless an alternative
- •causative factor [eg, Gilbert’s syndrome] is identified)
- •17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin
- •(LMWH), porcine products, or iodinated contrast medium (for venogram)
- •18) Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
- •19) Current use of dextrans or fibrinolytics (but the use of synthetic colloids like
- •pentastarch and hetastarch as blood substitutes is allowed)
- •20) Treatment with medications affecting coagulation or platelet function as follows:
- •Unfractionated heparin, LMWH, warfarin (or any other VKA), glycoprotein
- •IIb/IIIa inhibitors (eg, abciximab, eptifibatide, tirofiban) within 4 days before
- •Acetylsalicylic acid > 165 mg/day within 4 days before surgery
- •Clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone within 7 days before
- •Non-selective NSAIDs with a T1/2 greater than 17 hours (eg, Piroxicam and
- •Tinoxican) within 7 days before surgery
- •Fondaparinux within 7 days before surgery
- •Anti-fibrinolytics, with exception of the use of tranexamic acid where it
- •represents standard of care for the investigator
- •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.
- •22) Prisoners or subjects who are involuntarily incarcerated.
- •23) Subjects who are compulsorily detained for treatment of either a psychiatric or
- •physical (eg, infectious disease) illness.
- •24) Subjects who have been previously randomized into an apixaban clinical trial.
- •25) Administration of any investigational drug currently or within 30 days prior to
- •enrollment into this study.
- •26) Any other contra-indication listed in the country specific labeling for enoxaparin.
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