CTRI/2015/03/005598招募中4 期
A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in IndianSubjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery (Protocol # CV185-158)
Bristol Myers Squibb and Pfizer0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Signed Written Informed Consent
- •a) Age >18 years
- •b) 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) Target Population
- •a) Subjects undergoing elective total knee or hip replacement or a revision of at least one
- •component of a total knee or hip replacement.
- •3) Age and Reproductive Status
- •a) Women of childbearing potential (WOCBP) and men must be using an acceptable
- •method of contraception to avoid pregnancy throughout the study in such a manner that
- •the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP.
- •b) 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
- •c) Women must not be breastfeeding
- •d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
排除标准
- •1) Target Disease Exceptions
- •a) Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first
- •degree relative
- •b) Known coagulopathy
- •c) Active bleeding or at high risk for bleeding.
- •2) Medical History and Concurrent Diseases
- •a) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
- •b) Active hepatobiliary disease
- •c) Alcohol and/or substance abuse within the past year
- •d) Any condition, in the opinion of the Investigator, for which surgery or administration of
- •an anticoagulant is contraindicated.
- •3) Physical and Laboratory Test Findings
- •a) Two consecutive blood pressure readings within 15-30 minutes with supine SBP 180
- •mm Hg or supine DBP 105 mm Hg
- •b) Hemoglobin 9 g/dL
- •c) Platelet count 100,000/mm3
- •d) Creatinine clearance 30 mL/min as estimated by the method of Cockcroft and Gault
- •e) Active hepatobiliary disease, based on an ALT or AST 2 x ULN or a Total Bilirubin
- •ï?³ 1.5 x ULN (unless an alternative causative factor [eg, Gilbertâ??s syndrome] is identified.
- •4) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
- •the entire treatment period of the study
- •b) Women who are pregnant or breastfeeding
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product
- •administration.
- •5) Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical
- •(eg, infectious disease) illness
- •c) Administration of any investigational drug currently or within 30 days prior to enrollment
- •into this study.
- •6) Prohibited Treatments and/or Therapies
- •a) Dual antiplatelet therapy (eg, aspirin and clopidogrel)
- •b) Vitamin K antagonist or other novel oral anticoagulant (such as rivaroxaban or
- •dabigatran) during the treatment period
- •c) Ongoing unfractionated heparin or low molecular weight heparin use
- •d) Use of thrombolytics within past 7 days
- •e) Use of Fondaparinux.
研究者
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