EUCTR2006-003674-96-DE进行中（未招募）不适用
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safetyand Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely IllMedical Subjects During and Following Hospitalization.ADOPT: Apixaban Dosing to Optimize Protection from ThrombosisAnd Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007)Revised Protocol Number 01 incorporating Amendment 02 and Admin Letter 01 (Version 5.0, dated 25-Jan-2008)Protocol Amendment 03 dated 26-Feb-2009Revised Protocol 02 incorporating Amendment 04 version 7.0 dated 26-Feb-2009 - ADOPT
Bristol Myers Squibb0 个研究点目标入组 7,502 人开始时间: 2007年8月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,502
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 screening.
- •2) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel
- •3) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including:
- •a) age = 75
- •b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks
- •d) BMI = 30 (See Appendix 4 for BMI chart)
- •e) estrogenic hormone therapy
- •f) chronic heart or respiratory failure
- •4) Expected hospitalization of = 3 days after randomization
- •5) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6.9.1)
- •6) Men and women, of any race, at least 40 years of age
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 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 study period
- •2) WOCBP using a prohibited contraceptive method
- •3) Women who are pregnant or breastfeeding
- •4) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration
- •5) Subjects with a confirmed VTE
- •6) Subjects with diseases requiring ongoing treatment with a parenteral or oral
- •anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation
- •7) Subjects with conditions requiring ongoing treatment with parenteral or two or more oral antiplatelet agents
- •8) Active liver disease as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
- •9) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
- •10) Severe renal disease as evidenced by creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault (see Section 6.3.1.2)
- •11) Subjects hospitalized more than 72 hours prior to randomization
- •12) Subjects who are unable to take oral medications
- •13) Subjects who have had surgery in the past 30 days that may be associated with a risk of bleeding
- •14) Subjects who in the past 14 days have received treatment over consecutive days with: more than three doses of enoxaparin or another low molecular weight heparin; more than three doses of fondaparinux; more than six doses of unfractionated heparin; an infusion of unfractionated heparin for more than 72 hours; or more than two doses of an oral anticoagulant.
- •15) Subjects with active bleeding or high risk of bleeding
- •16) Subjects with planned or scheduled invasive procedures during the treatment period
- •17) Subjects in whom in the opinion of the Investigator it is not possible to obtain an
- •adequate bilateral compression ultrasound evaluation
- •18) Subjects with acute shock
- •19) Subjects with a life expectancy < 1 month
- •20) Abnormal hematological findings:
- •Hemoglobin < 9 g/dL
- •Platelet count < 100,000/mm3
- •21) Abnormal liver function tests:
- •ALT or AST > 3 X ULN or
- •ALT or AST > 2 X ULN without identification of an alternative causative factor or
- •bilirubin (direct or total) > 1.5 X ULN (unless in an alternative causative factor
- •[e.g., Gilbert’s syndrome] is identified)
- •22) Known or suspected allergies to enoxaparin or prior heparin-induced
- •thrombocytopenia
- •23) Use of bevacizumab (Avastin®) therapy within the previous 6 months or planned use during the study period
- •24) Presently receiving oral anticoagulant therapy
- •25) Presently receiving dual oral antiplatelet therapy or aspirin at a dose > 165 mg.
- •26) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study
- •27) Administration of any investigational drug currently or within 30 days prior to
- •planned enrollment into this study
- •28) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the minimum treatment duration of 6 days
- •29) Subjects unwilling or unable to comply with study procedures (e.g., bilateral
- •compression ultrasound) specified in the protocol
- •30) Subjects who have previously been randomized in an experimental study of apixaban
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